Quality Engineer jobs at BioFire Diagnostics

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. Provide work product updates to clients and project teams in the form of slides, memos and reports. Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field Knowledge and 8+ experience in a GMP API setting. Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. Knowledge and experience in process validation studies at the bench and in a plant setting. Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: NoShift: DayDuration: No End DateJob Function: R&D

We anticipate the application window for this opening will close on - 31 Dec 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including: * Creating and managing risk management plans and reports, as well as conducting regular risk reviews. * Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. * Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts. * Analyzing and reviewing product complaints to anticipate and prevent future issues. * Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed. * Implementing and maintaining robust product security measures to protect against potential vulnerabilities. * Developing and managing post-market surveillance plans to monitor product performance and safety in the field. * Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation Other potential responsibilities * Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. * Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. * Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. * Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. * Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. Qualifications: Minimum Requirements: * Education: Bachelor's degree in Engineering, or a related technical field. Advanced degree preferred. * Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards. * Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis. * Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders. * Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously. Preferred Qualifications: * Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred. * Experience: Experience in Quality Assurance, Engineering, Capital equipment * Industry Experience: Medical device industry. * Technical Skills: Proficient in quality assurance practices, risk management, and regulatory compliance. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$119,200.00 - $178,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We anticipate the application window for this opening will close on - 31 Dec 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** Responsibilities may include the following and other duties may be assigned. + Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. + Collaborates with engineering and manufacturing functions to ensure quality standards are in place. + Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. + Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. + Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. + May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. **TECHNICAL SPECIALIST CAREER STREAM:** An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. **DIFFERENTIATING FACTORS** **Autonomy:** Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists. **Organizational Impact:** Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. **Innovation and Complexity:** Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. **Communication and Influence:** Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. **Leadership and Talent Management:** Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. **Required Knowledge and Experience:** Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$119,200.00 - $178,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans (************************************************************************************************************** **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (************************* . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will... + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email ******************* To request removal of your personal information from our systems please email *****************************

We anticipate the application window for this opening will close on - 31 Dec 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. * Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. * Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. * Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. * May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$119,200.00 - $178,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging. **What You Can Expect** Paragon 28, a Zimmer Biomet Company, is hiring a Quality Engineer I - Production. The Quality Engineer has varied responsibilities to assist the Quality team in ensuring compliance to regulations and standards. This position is onsite at our Englewood, Colorado location. **How You'll Create Impact** - Create and revise components of the Quality System - Manage and complete CAPAs on the quality system - Perform internal audits, as needed - Assist Design Quality Engineers in completion of NCRs, Complaint investigations and other project related work as needed - Work with the supplier quality and purchasing departments to evaluate new suppliers and pre-production approvals - Assist in establishing receiving inspection criteria with input from Product Development, Engineering and QA - Execute equipment validations - Other duties as assigned **Your Background** - Bachelor's in Engineering or technical discipline and 2 years of related experience - Medical device experience preferred - Knowledge and experience with measuring equipment - Process Validation experience preferred - Experience reading and interpreting part drawings/GD&T and use of measuring equipment a plus - Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards - Strong computer skills (MS Word & Excel) - Knowledge of Ti and SS machining a plus **Travel Expectations** Less than 10% overnight travel. **Compensation Data** Salary Range: $70,000 - $90,000 USD annually depending on skills and experience EOE

Description & Requirements Maximus is currently hiring for a Quality Assurance Manager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri. *This job is contingent upon contract award.* At Maximus we offer a wide range of benefits to include: - • Competitive Compensation - Quarterly bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave, - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities- Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Oversee the day-to-day functions of the Quality Assurance (QA) department. - Manage an effective quality assurance program that monitors and resolves issues before they become problems. - Supervise the development and regular update of policies and procedures. - Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers. - Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements. - Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures. - Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution. - Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. Home Office Requirements: - Internet speed of 20mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. #max Priority EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 80,000.00 Maximum Salary $ 95,000.00

Description & Requirements Maximus is currently hiring for a Quality Assurance Manager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri. *This job is contingent upon contract award.* At Maximus we offer a wide range of benefits to include: - • Competitive Compensation - Quarterly bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave, - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities- Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Oversee the day-to-day functions of the Quality Assurance (QA) department. - Manage an effective quality assurance program that monitors and resolves issues before they become problems. - Supervise the development and regular update of policies and procedures. - Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers. - Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements. - Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures. - Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution. - Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. Home Office Requirements: - Internet speed of 20mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. #max Priority EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 80,000.00 Maximum Salary $ 95,000.00

Quality (QA/QC) Supervisor This position will report to the Site Quality Manager. The Quality Supervisor evaluates, tracks, trends, and monitors the Quality Assurance and Control activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites. Moreover, the role is responsible for promoting our mission of improving patient outcomes with high quality outsourced pharmaceuticals. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met. Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures. Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning. Review and approve criteria for analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are performed. Review and approve maintenance activities for processes and equipment. Ensure that the required initial and continuing training of personnel is carried out and adapted according to need Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization. Supporting or performing internal audits. Supporting external regulatory or customer audits. Gather information from multiple departments for trending and presentation to management. Identify trends in the industry and recommend improvements Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control Other duties as assigned. Supervisory Responsibilities: Foster a positive and productive work environment, providing guidance, coaching, and mentoring. Conduct regular 1:1's to address performance, feedback and relationship building. Identify training and development needs within the team and facilitate as able. Experience and Necessary Skills: Bachelor's Degree (Science discipline preferred) and/or commensurate experience required 1-3 years of experience in supervising in a cGMP FDA regulated pharmaceutical manufacturing environment Knowledge of cGMP guidelines/standards and ability to identify potential adverse issues. Able to work in a fast-paced environment and adaptable to change. Demonstrated written and oral communications skills including strong presentation skills. Strong results orientation and attention to detail. Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs Must pass English Competency Test Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket! Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation, sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Shift: Monday-Friday 11:30pm-8am Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

We anticipate the application window for this opening will close on - 26 Dec 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the LifeThe Manufacturing engineering position will focus on supporting sustaining optimization projects and qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders. The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed. Manufacturing Engineer II Location: Onsite, Boulder, Colorado 100% The Manufacturing engineering position will focus on supporting sustaining optimization projects and qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders. The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed. Responsibilities may include the following and other duties may be assigned. Develop and execute validation strategy of various changes including scrap reduction, fixture improvements, supplier changes, and equipment optimization Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality Provides guidance regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures comply with applicable regulations. Additional Responsibilities Ensures reliability, develops technical specifications for production, analyzes configuration and processing solutions, and tests product conformance to specifications. Collaborates with research, design, development, and testing for product improvement projects. Knowledge/Skills/Abilities: Mechanical aptitude. Strong computer skills, including Microsoft Word, Microsoft Excel, Microsoft Project, Minitab, etc. Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports. Knowledge of GMP and ISO regulations (Design Controls). Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct Must be able to work in a dynamic environment with little supervision or daily direction Strong, team-oriented professional with good interpersonal skills and project management experience. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience. Nice to Have Electrical, Mechanical, or Electromechanical degree Medical Device experience Experience with equipment development and process validation (IQ/OQ/PQ) Small tooling design and development Engineering experience with medical devices Design of Experiments (DOE) Electro-Mechanical troubleshooting skills Strong statistical skills using Minitab Six Sigma Lean Manufacturing experience preferred NCMR, CAPA, and Audit experience Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$81,600.00 - $122,400.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Job TitleAdvanced Manufacturing Engineer 1Job Description In this role you will drive and deliver innovation within the area of process development for new product introduction; ensure that manufacturing processes are capable, scalable, and stable against specifications and requirements; and identify and recommend solutions for complex technical issues in a regulated environment. Your role: Initiating and partnering with AME teammates in the development of processes within the phases of a PDLM (Product Design & Lifecyle Management) of new medical device products. Be an essential cross-functional teammate in initiating and delivering on product industrialization activities, including equipment selection, process automation, process characterization, and process validation. Align and represent the team in areas DFx. With a focus on design for manufacturability, reliability, serviceability, and test. Driving and making data-driven decisions on key performance indicators such as cost of goods (COGS), yield, output, quality throughout projects, and into commercialization Develop your technical career by becoming a subject matter expert in your work, and put your engineering skills to the test in complex problem-solving. You're the right fit if: You've acquired 4+ years of experience with a vocational education in such areas as manufacturing/operations environment, engineering, industrial engineering, system engineering, production engineering, or cost engineering. No prior experience needed with a Bachelor's degree in the above areas Your skills include a breadth of knowledge in manufacturing production processes and experience in how changes to existing products impact cost, performance, quality, and throughput; experience in process development and continuous improvement with a focus on automation, a data-driven mindset with a background in statistical tools. Preferred skills: experience in manufacturing and continuous improvement with an ISO 13485 or other regulated environment and familiarity with Test Method Validations (TMV), IQ/OQ/PQ You have a bachelor's degree or vocational education in mechanical engineering, electronics engineering sciences, cost engineering, manufacturing engineering, lean engineering or industrial automation You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're passionate about delivering innovative technical solutions in a manufacturing team-based environment, you're self-motivated but able to build a network and learn quickly from others, recognize problems and take corrective action when appropriate; familiarity with working on complex issues with cross-functional team members to achieve effective resolution, and communicating needs and progress to stakeholders How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in Colorado is $67,500 to $108,000 The actual base pay offered may vary within the posted ranges depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Validated Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field. * 4+ years relevant experience and/or training; or equivalent combination of education and experience. * 3+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least November 26, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $87,600.00 - $136,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D

"What's it like to work at Agilent in Manufacturing? Watch the video" Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** Want to take your knowledge and experience further? Ready to provide technical leadership and make key decisions? This is your opportunity - not only to join a committed, professional, and forward-thinking team but also to lead in the design and implementation of complex manufacturing processes and transform broad concepts into structured results-focused projects. Join a growing team with this exciting new opportunity for an Process Engineer at our Boulder, Colorado GMP facility. Work in our dynamic, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics. Responsibilities may include but are not limited to: Provide project/process engineering support of a GMP manufacturing process (Upstream, Midstream, Downstream, Utilities). Responsible for any area of focus with the existing manufacturing process. Area of focus will also be supported during projects. Supporting small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design integration, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing. Participate with project management through coordination of multi-disciplinary teams. Collaborate with Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing. Collaborate and facilitate project EHS activities including Process Hazard Analysis, Safety Checklist, and PSM compliance to meet OSHA standards. Ensure for all projects a high level of cGMP compliance to meet the ICH requirements for pharmaceutical buildouts. Support Validation activities including review of Factory Acceptance Test and Site Acceptance Test (FAT/SAT) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ) protocols, participating in IOPQ execution, and review of final reports. Support regulatory activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses. Integrate with Manufacturing and Quality Assurance groups with day-to-day troubleshooting and maintenance activities for projects/process, through identification of process improvement and optimization opportunities, including review of SOPs and MBRs. Perform job functions and responsibilities independently and with limited direction. Leads the development, design of new product/ process technology advancements; is the key technical contributor. Solves complex, high impact design/ development problems. Qualifications Bachelor's or Master's Degree in Mechanical, Electrical, or Chemical Engineering or equivalent education/experience. 4+ years of combined experience in pharma/biopharma and fine chemicals industry to include 3+ years of experience with process and instrumentation diagrams, facility layouts, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs) and process troubleshooting. Preferred Skills: 2+ years of experience supporting small to large-sized projects through all phases, including architectural and engineering design, design review, process safety management, process hazard analysis, equipment procurement, installation, commissioning, and qualification, is desirable. Self-motivated, hands-on problem solver with the ability to work within multi-disciplinary teams, including process development, manufacturing, validation, quality, safety, and project management personnel. Familiarity with current ASME BPE sanitary piping and equipment design standards, electrical standards such as National Fire Protection Association / National Electrical Code (NFPA 70 / NEC) and International Fire and Building Codes. Project Management experience in biopharma. Experience with design and programming of industrial control systems, including SCADA, PLCs, and BAS and validation documentation, including installation, operational and performance qualification (IQ/OQ/PQ) protocols. Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract manufacturing facility. #LI-DT1 Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least November 10, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $103,200.00 - $161,250.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: 10% of the TimeShift: DayDuration: No End DateJob Function: Manufacturing

Duties and Responsibilities: Work effectively with the Quality, Operations, and R&D departments to perform all work accurately, with a sense of urgency and a positive attitude. Activities include the following: In-Process and Final Device Inspection and Test : Support Manufacturing as the QC inspector for clean-room & packaging inspection activities. Perform and document in-process and final inspection/test of devices and sub-assemblies. Provide inspection/test assistance to R&D, Operations and Quality Engineering in support of design and process verification/validation activities. Receiving Inspection and Test : Perform and document receiving inspection/test of device components & raw materials in accordance with drawings/specifications. Maintain accurate & timely records of inspection activities and recording such activities in the QC Receiving Log. Non-Conforming Materials : Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Initiate NCRs and notify the workstream owner in a timely manner. Execute and record disposition activities in accordance with approved NCRs. Microbiological Monitoring : Participates in periodic microbiological and particulate testing of the cleanroom and products as required. Returned Goods Authorization : Perform timely inspections and maintain accurate records of all returned TriSalus products through the RGA process. Correctly dispositions returned product as defined in approved procedures. Quality Record maintenance : Receive, verify, scan and physically file Quality Records in an organized manner as needed. Shipping QC : Verify TriSalus products and associated paperwork are accurate and complete prior to shipment. Audit Assistance : Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar). GP Dynamics : Transfer released materials in the ERP software for material management as needed. Training Record support : Enter complete training/certification records into the eQMS as needed. General : Perform other quality inspection, test or administration activities as assigned. Qualifications Education & Certifications: High School diploma. Advanced education or certifications a plus. Work Experience: 2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company. Experience working with sterile disposable products in a cleanroom environment a plus. Knowledge, Skills & Abilities: Able to read and interpret engineering drawings, specifications and detailed technical documents. Able to read and follow quality procedures and detailed work instructions (QLPs/OPs). Able to perform component and product inspection/testing using tools such as microscopes, calipers, micrometers, pin gauges, depth gauges, pull force test systems and vision measuring systems. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy. Able to accurately document results of inspections using good documentation practices. Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4. Able to utilize basic math skills. Able to use MS Word and MS Excel. Must possess strong attention to detail. Possess good communication skills and able to interact with peers in a professional manner. Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485). Demonstrates excellent critical thinking skills. Ability to adapt to and rapidly learn new processes. Strong verbal and written communication skills and confidence in making inspection related decisions. Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed. Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve. Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Must be able to lift and carry up to 30 lbs. Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

Validation Engineer The Validation Engineer reports directly to the Validation Manager. The role is responsible for acting as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, shipping validation, and program maintenance. The Validation Engineer will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. This role ensures all systems operate under regulations to ensure the production of quality products for the Company's 503B cGMP manufacturing facility. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Works on projects/matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group. Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team. Completes tasks in a timely fashion and communicates task status to management and/or project team. Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs. Coordination of Validation activities with stakeholders. Supports in writing and executing protocols for Validation work. Identifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions. Generates reports and summarizes results, including confirming the document is suitable to be shared with regulatory agencies. Supports creation or revision of Validation templates for protocols and reports. Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT). Supports project work as a specialist on complex technical matters. Supervisory Responsibilities: N/A Experience and Necessary Competencies: Bachelors degree in STEM field required; i.e. engineering, chemistry, or relevant industry experience. 4+ Years of validation experience preferably in a highly regulated environment. Experience in project management preferred Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.) Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through. Willingness to support tasks outside normal job description, as needed. Can-do attitude! Ability to create technical and professional documents. Strong attention to detail and accuracy. Ability to multi-task, with strong organization and time-management. Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis. Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus! Proficient written, verbal and oral English communication skills are required. Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: Ability to stand or sit for extended periods of time. Ability to lift, push and pull up to 50 pounds periodically. Ability to maintain a gowning qualification and adhere to aseptic practices. Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation, sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

Validation Engineer The Validation Engineer reports directly to the Validation Manager. The role is responsible for acting as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, shipping validation, and program maintenance. The Validation Engineer will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. This role ensures all systems operate under regulations to ensure the production of quality products for the Company's 503B cGMP manufacturing facility. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Works on projects/matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group. Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team. Completes tasks in a timely fashion and communicates task status to management and/or project team. Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs. Coordination of Validation activities with stakeholders. Supports in writing and executing protocols for Validation work. Identifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions. Generates reports and summarizes results, including confirming the document is suitable to be shared with regulatory agencies. Supports creation or revision of Validation templates for protocols and reports. Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT). Supports project work as a specialist on complex technical matters. Supervisory Responsibilities: N/A Experience and Necessary Competencies: Bachelors degree in STEM field required; i.e. engineering, chemistry, or relevant industry experience. 4+ Years of validation experience preferably in a highly regulated environment. Experience in project management preferred Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.) Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through. Willingness to support tasks outside normal job description, as needed. Can-do attitude! Ability to create technical and professional documents. Strong attention to detail and accuracy. Ability to multi-task, with strong organization and time-management. Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis. Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus! Proficient written, verbal and oral English communication skills are required. Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: Ability to stand or sit for extended periods of time. Ability to lift, push and pull up to 50 pounds periodically. Ability to maintain a gowning qualification and adhere to aseptic practices. Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation, sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

WHO WE ARE Biofire Technologies is on a mission to give gun owners better tools for reducing preventable gun injuries and deaths, especially among children. We believe our technology, combined with a best-in-class customer experience, will define the future of firearms safety for the next generation. Our mission-driven approach has earned support from the firearm community, the tech world, and the media. Biofire employees encompass a diverse range of talents, including world-class engineers who have designed and tested firearms, medical devices, robots, cars, satellites, rockets, and supersonic jets; expert technicians from aerospace, defense tech, special forces, and gunsmithing; and elite operators from high-tech, advanced manufacturing, and regulated industries. Whether building the product or powering the company behind it, every Biofire team member is united by an obsession with safety, reliability, and operational excellence. OUR CULTURE Reducing accidental firearm injuries and deaths requires original thinking and authentic collaboration, so we're deeply invested in building a team and culture that can achieve our mission together. Team members enjoy autonomy and flexibility from day one, so expect to be immediately tasked with solving challenging problems and building new systems that work. We'll hold you accountable for executing audacious goals, giving and receiving honest feedback, and helping your teammates succeed. You'll receive respect, kindness, and support from every direction while you figure out how to get it all done. ABOUT THE ROLE As a Quality Generalist on our Manufacturing Team, you will be the linchpin of our quality assurance efforts. Your primary focus on inspection will be instrumental in upholding the highest product quality. Collaborating seamlessly with diverse teams, you'll play a key role in refining processes, conducting thorough inspections, and driving continuous improvement initiatives to ensure our products are of the utmost quality. To succeed you will need to be able to integrate seamlessly with our manufacturing and quality teams, leveraging your inspection expertise to elevate our product quality while also being willing to contribute to ad-hoc projects from time to time. By demonstrating a commitment to continuous improvement, proactive problem-solving, and a keen attention to detail, you will contribute significantly to our mission of setting new standards in manufacturing excellence. If you're excited about advancing Biofire's mission, we encourage you to apply. KEY RESPONSIBILITIES Day-to-day responsibilities of the role will include: * Operate incoming‑material test equipment, running engineering-defined CMM protocols on incoming mechanical fabricated parts; * Conduct general part inspections (dimensional, visual, and functional) using our broad array of precision tools; * Read and interpret engineering drawings and blueprints to extract inspection requirements and Geometric Dimensioning and Tolerancing (GD & T) callouts; * Define our inspection processes as we scale, including what to inspect, how, and selecting the appropriate measurement tool for each task; * Accurately record inspection data in our quality‑management system, maintaining traceability of lot numbers and inspection outcomes; * Identify nonconformances, apply hold tags, and collaborate with Internal Quality, Supply Chain and Suppliers on root‑cause analysis and corrective actions; * Support continuous‑improvement initiatives: Refine inspection plans, reduce cycle times, and standardize best practices; QUALIFICATIONS We understand that not all applicants will possess skills that perfectly align with our job qualifications. At Biofire, we appreciate diverse experiences from various industries, and we encourage all individuals who meet the necessary qualifications to submit their applications. While having the "desired" qualifications may strengthen a candidate's profile, we also welcome applicants with alternative experiences to apply. * 5 - 10 years of hands‑on quality‑inspection experience in manufacturing, new product introduction in the aerospace, automotive, consumer electronics or medical device industries, including: * The ability to operate existing CMM programs on a Zeiss CMM, ideally with Calypso software. * The ability to make modifications to / to create new CMM programs given an inspection drawing. * The ability to maintain, calibrate, service (either individually or through contract) CMM equipment. * Strong technical literacy: Proven ability to read and work from engineering drawings, schematics, and technical documents, including a solid understanding of GD&T concepts and symbols. * Demonstrated skill selecting and using precision measurement tools. * Experience collaborating with cross-functional teams (Engineering, Supply Chain and Suppliers) to identify systemic quality issues and improve real-world hardware. * Proficiency with quality documentation software (1Factory, Arena, etc.), task tracking software such as Jira, and general computer proficiency. * Strong attention to detail and a disciplined, process‑driven mindset. * Excellent communication, documentation, and organizational skills. * Ambition to improve the quality function at Biofire by developing inspection plans, making operational quality decisions, and supporting New Product Introduction. COMPENSATION AND BENEFITS In addition to competitive pay, as a full-time employee at Biofire you are eligible for: * Stock Options in Biofire, 401(k), HSA - and other financial benefits * Medical Insurance - including plan options with $0 payroll deduction * Dental, Vision and Life Insurance Plans - with $0 payroll deduction * 3 Weeks Vacation and Sick time (Flex Time for salary positions), and 13 Paid Holidays * Parental Leave - and other family-building, adoption and surrogacy benefits The compensation range for this role is $40.00 - $50.00/hour + stock options + benefits. Pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. LOCATION This is a full-time, hourly role that will require you to be on-site. Our dog-friendly, state-of-the-art headquarters is located in beautiful Broomfield, Colorado, between Boulder and Denver. This position will require overtime work to meet project deadlines. The ability to work beyond regular hours, including evenings and weekends, is essential. We expect you to bring your very best, and in return, we will provide the support necessary for you to excel. You'll collaborate with colleagues you appreciate, respect, and find inspiration from, and have access to all the technical resources required at our Broomfield office. DIVERSITY & INCLUSION We're bringing innovation to a technological problem that has persisted for decades, so we depend on diverse, inclusive, and collaborative teams to break new ground and do great work. We welcome people from all qualified backgrounds, and we don't discriminate based on race, religion, color, political affiliation, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. ELIGIBILITY This role handles information subject to US Export Control Regulations. Applicants must be (a) a citizen of the United States; (b) a lawful permanent resident of the United States ("Green Card" holder); or (c) a person admitted into the United States as an asylee or refugee to be considered for the position.

Duties and Responsibilities: Participate in the development and improvement of manufacturing processes for SmartValve Manufacturing and catheter-based systems in accordance with FDA and international regulations. Evaluate, develop, and sustain processes to meet product performance and manufacturing yield requirements. Constantly identify opportunities to reduce cycle time and waste. Develop and implement plans to capitalize on these opportunities. Evaluate and modify process flow as necessary to improve efficiency. Develop tools, fixtures, and processes to meet product and process capability requirements. Create and maintain process validation master plan. Develop, qualify, and validate new manufacturing processes as needed. Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Build and validate test equipment, conduct testing of product, and analyze data as needed. Follow approved procedures for activities conducted and update or generate new procedures as needed. May supervise operators, technicians, or other engineers. Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. Assure individual and group safety when conducting all activities. Maintain effective communications with supervisor and peers in project activities. As necessary, suggest strategic direction for specific projects. Support day-to-day manufacturing activities. Qualifications Education & Certifications: Minimum of four-year engineering degree or equivalent experience. Work Experience: 0-2 years experience in a medical device manufacturing environment is required. Knowledge, Skills & Abilities: Cardiovascular catheter experience preferred; will consider candidates with self-expanding stent experience. Knowledge with chemistry and good laboratory practices. Familiarity with Six Sigma principles preferred. Physical Requirements: Able to work in an industrial environment.