R&D Senior Engineer II
Alpharetta, GA jobs
Job Title: R&D Senior Engineer II
Job Country: United States (US)
Here at Avanos Medical, we passionately believe in three things:
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.
At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit ***************
Essential Duties and Responsibilities:
The R&D Senior Engineer II plays a key role in Avanos' New Product Development (NPD) organization, contributing to the design, development, and commercialization of innovative medical devices that advance patient care. This position combines hands-on design ownership, strong technical problem-solving, and cross-functional collaboration to ensure products meet user needs, regulatory requirements, and business objectives.
The R&D Senior Engineer II is responsible for leading design workstreams within complex programs, mentoring junior engineers, and ensuring engineering excellence throughout the product development lifecycle.
Key Responsibilities:
Lead design and development activities for assigned subsystems or product components through all phases of the PDP.
Develop and refine 3D CAD models, detailed drawings, specifications, and tolerance analyses consistent with design control and DFM/DFA principles.
Conduct and document design reviews, FMEA, and risk assessments to ensure robust performance, reliability, and patient safety.
Collaborate with cross-functional partners (Systems, Quality, Regulatory, Clinical, Technical Operations, Project Head) to translate user needs and system requirements into actionable design inputs.
Support prototype builds, design verification and validation testing, and root cause analysis for design issues.
Apply sound engineering principles in areas such as mechanical design, fluidics, and electromechanical integration to develop effective solutions.
Work Technical Operations teams to ensure designs are manufacturable, cost-efficient, and scalable.
Mentor and provide technical guidance to junior engineers within the team.
Support intellectual property development through design innovation and technical documentation.
Your qualifications
Required:
B.S. degree in Mechanical, Biomedical, or related Engineering discipline.
6+ years of experience in medical device design and development.
Strong proficiency in 3D CAD (SolidWorks preferred), GD&T, and mechanical design fundamentals.
Demonstrated experience leading design efforts for Class II or III medical devices.
Solid understanding of risk management, verification/validation testing, and documentation best practices.
Proven ability to solve complex technical problems and drive projects to completion in a matrixed environment.
Excellent written and verbal communication skills, with attention to design documentation and traceability.
Preferred:
Experience with electromechanical systems, fluid delivery, or disposable/reusable medical device interfaces.
Working knowledge of materials selection, molding processes, or sterilization methods (EO, gamma, e-beam).
Experience collaborating with contract manufacturers or development partners.
Participation in IP generation or patent applications.
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Salary Range:
The anticipated average base pay range for this position is $104,000.00 - $121,000.00. In addition, this role is eligible for an attractive incentive compensation program and benefits. In specific locations, the pay range may vary from the base posted.
Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here
Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.
Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.
Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
Avanos also offers the following:
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions
Mechanical Engineer
Rice Lake, WI jobs
*About us* Thomas Precision has been a leading manufacturer of parts and service to the food processing industry since 1981. Located in scenic NW Wisconsin, we take pride in bringing quality products and service to our customers. We are currently seeking a full time Mechanical Engineer to join our growing team.
*Position Responsibilities*
* Investigate and evaluate new manufacturing product lines and related processes.
* Oversee all stages of new product & process development, including:
* New component and machine designs
* Manufacturing processes/techniques
* Manufacturing cost reduction
* Working directly with customers at their facilities to investigate new opportunities and test designs
* Provide troubleshooting and technical support to TPM customers, sales department, and manufacturing for existing components and machines.
* Develop and implement manufacturing automation projects.
* Up to 10% travel required.
*Qualifications*
* Excellent written and verbal communication skills.
* Ability to self-direct own work and manage projects to ensure they are technically sound and conform to scope, timeframe, and budget.
* Especially valued for this position would be knowledge/experience in:
* A production machining environment
* Material properties and analysis
* Castings, weldments, metal coatings
* Use of CAD software
* Some electrical, controls, and/or PLC experience a plus.
* The ability to work independently and directly with customers on-site and on the road to make engineering design and process decisions.
* A strong background of work related to mechanical or manufacturing engineering is preferred.
* A 4-year degree in Mechanical Engineering, Manufacturing Engineering, or equivalent is required.
* Please note: This is an on-site position. Remote or hybrid work arrangements are not available.
*Why work for us?*
We offer a competitive salary, great working environment, and full benefit package including: 401K with company match, PTO, 9 Paid Holidays, Health Insurance/HSA, FREE Dental , Company paid Short Term Disability, Life Insurance and Voluntary Benefits.
_We do not discriminate on the basis of race, religion, national origin, color, sex, age, veteran status, or disability. It is our intention that all qualified applications be given equal opportunity and that selection decisions are based on job-related factors._
Job Type: Full-time
Application Question(s):
* Are you willing to travel up to 10% of the time. Travel may include working in wet food processing environments.
* Please list 2-3 dates and times that you would be available for a preliminary phone interview.
Education:
* Bachelor's (Preferred)
Ability to Commute:
* Rice Lake, WI 54868 (Required)
Work Location: In person
Senior Project Engineer
Kansas City, MO jobs
Senior Project Engineer - Commercial
Kansas City, MO
Are you the type of professional who puts just as much care into managing relationships as you do into managing projects and supporting your team? Are you equally skilled at explaining contracts as you are at scoping them? Are you ready to join a Commercial General Contractor that will help you thrive?
We're looking for a Senior Project Engineer to play a key role in the delivery of complex commercial projects, working closely with clients and the project team. That Senior Project Engineer could be you.
Why You'll Love Us
Competitive pay and a comprehensive benefits package
An engaging workplace and exciting projects that make an impact
Innovative and sustainable business practices that set us apart
A team that gets things done!
What You'll Do
Take ownership of quality control and assurance across commercial projects. Plan your work and work your plan, overcoming obstacles and driving projects forward with confidence and clarity. Manage RFIs, submittals, change orders, claims, and other critical documents. Support and lead coordination across the project team and serve as the main point of contact with subcontractors. Stay ahead on site documentation, changes, and cost implications while ensuring all safety protocols are followed. Mentor junior engineers and help grow the team.
A Little More About You
Minimum 5 years of related experience in commercial construction
Degree in Construction Management, Civil Engineering, or related field
Reliable, personable, and someone others enjoy working with
Strong leadership skills with the ability to mentor others
Excellent communication and relationship-building skills
Experience with construction software preferred
Ability to prioritize and manage time effectively
Strong decision-making skills, you'll often be the one making the final call
If you're ready to take on challenging, meaningful projects and grow with a team that values your expertise, let's build something extraordinary together.
Lead Java Backend Engineer
Charlotte, NC jobs
Title: Lead Java Backend Engineer
looking for local candidates only who are comfortable for face to face interview
Qualifications:
Technical Skills:
· Strong expertise in Java, Spring, and Spring Boot
· Deep understanding of microservices architecture and best practices
· Proficiency in MySQL and relational database design
· Experience with AWS cloud services
· Familiarity with Hibernate (preferred)
· Knowledge of Docker, Kubernetes, and containerization (a plus)
Experience:
· Minimum 10+ years in backend development
· 2+ years of experience leading a development team
· Proven ability to design and implement scalable, high-performance systems
Soft Skills:
· Strong ownership mindset with a passion for driving change and setting standards
· Exceptional communication skills-able to bridge the gap between technical and non-technical stakeholders
· Ability to simplify complex concepts for the product team and business stakeholders
· Hunger for learning, innovation, and improving team efficiency
Bonus Points:
· Experience with Azure DevOps
· Strong understanding of CI/CD pipelines
· Exposure to event-driven architecture and Kafka
· If you're a self-driven engineer eager to take a team to the next level, build smart solutions, and set new industry standards, we'd love to hear from you!
Data Engineering & Analytics Lead
Jacksonville, FL jobs
The Alfred I. du Pont Charitable Trust is seeking an exceptional professional to join a leading investment management organization that invests exclusively for the benefit of pediatric healthcare. Today, the Trust's dedicated team manages over $10 billion in assets that provides support to The Nemours Foundation, a premier children's healthcare system that includes the Nemours Children's Hospital in Wilmington, Delaware and Orlando, Florida as well as Nemours Children's Clinics in Delaware, Florida, Pennsylvania, and New Jersey. Our work has provided nearly $5 billion for the care and treatment of children. With your help, we can continue our mission of serving hundreds of thousands of children each year. The Trust's headquarters is in Jacksonville, a fast-growing and affordable city in vibrant Northeast Florida.
The Trust seeks professionals who embody our values. We seek those who recognize that first and foremost, we are stewards of Mr. du Pont's mission. We are a professionally run asset management firm whose mission is to be a best-in-class investment organization. Across our team, there is alignment around our common purpose of having a meaningful and immediate impact on our business and the lives of children through our support of The Nemours Foundation. We have a mindset that we win together as one team and know that we can achieve more collectively than individually. We foster a collaborative, professionally humble, team-oriented work environment that encourages constructive debate, continuous improvement, and taking initiative. The Trust is an organization that values and rewards high performance and great results with competitive compensation and excellent benefits.
We are purposeful about the decisions we make, always mindful that decisions must be made with care and must reflect the strategy and the priorities of the organization and our stakeholders. We are fundamental investors operating within small teams under a collaborative decision-making process that values intellectual honesty and transparency in our process. The business team plays a critical role in providing timely information in support of our investment process and automating reporting and information availability that maximizes our investors' time spent finding exceptional investments. We proactively protect our assets namely, capital, people, property, and reputation. We execute our strategy with accuracy and efficiency while staying forward looking and innovative to be ready to meet tomorrow's challenges. Importantly, we are a team that shares responsibility for our outcomes. We value independent thinkers who communicate effectively and approach situations holistically with an eye toward efficiency without sacrificing quality and rigor. As a forward-thinking organization, we value intellectual curiosity and those who invite, challenge, and engage in discussion. The Trust environment is one in which team members are expected to develop professionally, share openly, and enjoy collaborating.
The Data Engineering & Analytics Lead role is a unique opportunity to architect and build a comprehensive data platform and software ecosystem on a modern tech stack. You will collaborate with leadership to shape the technical vision, strongly influencing the critical infrastructure that powers our investment decision-making.
THE ROLE
Manage the cloud data platform (Snowflake, Azure) and serve as the central architect for data integrity and storage.
Guide system modernization efforts and assist with "buy vs. build" decisions to ensure technology remains innovative.
Design and optimize end-to-end data pipelines and system integrations using SQL, Python (Fivetran), and APIs, implementing automated workflows, monitoring, and alerting to ensure pipeline stability and timely data refreshes.
Design and deliver high-quality custom software solutions and application layers, including Streamlit and Snowflake apps, to address specific business requirements.
Integrate AI solutions and develop customized workflows using LLM pipelines, RAG, text-to-SQL, embeddings, vector databases, and prompt engineering.
Lead the swift development of Power BI dashboards to provide actionable insights for multi-asset class portfolios.
Collaborate with internal and external partners to translate organizational needs into data solutions, working closely with stakeholders to refine and iterate on requirements.
Assist with the design, implementation, and configuration of core business systems, focusing on optimizing data input structures to ensure efficient downstream reporting.
Support a fast-paced environment by prioritizing quick iteration and continuous improvement while taking ownership of complex, high-visibility initiatives.
WHAT YOU BRING
Educational and Professional Experience:
Bachelor's degree (required) in Computer Science, Information Systems, Data Science, Engineering, or a related quantitative field.
5+ years of progressively responsible experience in data engineering, analytics, or BI platform development.
3+ years hands-on experience with Snowflake or comparable modern data warehouse (BigQuery, Redshift, Databricks).
Technical Skills:
Data Engineering: Advanced Python, SQL, dbt, orchestration tools, APIs/Fivetran, and CI/CD automation for complex multi-source ELT pipelines.
Analytics Engineering: Deep understanding of dimensional modeling, semantic layer design, data marts, and metric standardization for Power BI.
BI & Visualization: Expert Power BI development (DAX, tabular models, data lineage, and performance optimization at scale).
Data Governance & Reliability: Ability to design and enforce data quality frameworks, testing processes, and documentation standards.
AI & Automation: Working knowledge of LLM pipelines, RAG, text-to-SQL, embeddings, vector databases, and prompt engineering.
Cloud & DevOps: Strong environment management, containerization, monitoring, and automated alerting using modern cloud tools.
Leadership Skills:
Excellent communication and collaboration skills with technical and non-technical teams.
Proven project management and delivery experience
A generalist mindset that is comfortable wearing multiple hats across data engineering, analytics, and AI.
Passionate and self-motivated with genuine curiosity about data and a drive to learn new technologies and solve problems creatively
WHAT WE BRING
Professional Growth and Mentorship: Significant interaction with the Trust's senior professionals who bring a wealth of experience and are excited to mentor and support your career development.
Exposure to Leading Technology and Experts: Gain hands-on experience with top-tier technology, modern data and analytics solutions, and cutting-edge AI while expanding your expertise and network.
Purpose-Driven Impact: A shared commitment to making a meaningful difference in our business and in the lives of children through our support of the Nemours Foundation.
Collaborative Work Environment: A team-oriented culture where we believe in achieving more together than individually. We foster constructive debate, continuous improvement, and encourage taking initiative.
Competitive Compensation and Benefits: We value high performance and reward great results with a competitive base salary, excellent benefits, and bonus opportunities.
Atomic Solutions Field Application Engineer
Remote
To support our customers' success with Agilent's Atomic Spectroscopy portfolio, we are looking for an enthusiastic person to join our Professional Services consulting team. You will join a professional team of Field Application Engineers who support customers in the United States and Canada. You will be responsible for educating customers on the entire Agilent portfolio of Atomic Spectroscopy hardware and software and help them develop solutions to their specific application and analytical needs.
Your Role:
Your role is to provide our customers with post sales technical and application support on Agilent Atomic Spectroscopy (ICP-OES, ICP-MS and AAS) software and hardware products.
Delivery of customized consulting and application support both remotely and at customer sites. Overnight travel is required 75% of the time.
Interfacing with customers to answer questions and provide training using Agilent atomic spectroscopy products.
Contributing to the effective and expedient resolution of customer problems
Providing information to our Customer Service Organization that facilitates the transfer of knowledge and broadens organizational insight and awareness.
Leading the design/ delivery of integrated multiple technologies solutions; is the key contributor of technical expertise and business/ industry knowledge
Mentoring peers, colleagues and partners to drive workflow and application expertise.
Solving complex, high impact system/application engineering services problems
Qualifications
Master's or PhD in Chemistry/Biochemistry or another life-science discipline
At least 4 years of work experience with Agilent's ICP-OES, ICP-MS and AAS solutions with a deep understanding of workflow and applications
Expertise in atomic spectroscopy techniques, workflows and solutions
In-depth knowledge and experience in application implementation and troubleshooting
Ability to work independently
Excellent verbal, written, and presentation communications skills
Drive, energy, and self-motivation
Confidence to work independently and as part of a team
Ability to learn new technologies on your own
Proficiency in the use of Microsoft Office Suite
Available for flexible work schedule and (minimum) 75% business travel
Located within one hour drive of a major metropolitan airport.
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 December 22, 2025 or until the job is no longer posted. In the US, this position is eligible for reimbursement for personal vehicle usage.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: 75% of the TimeShift: DayDuration: No End DateJob Function: Services & Support
Auto-ApplyLead Product Security Engineer (R&D Cytology)
San Diego, CA jobs
Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
**Key responsibilities and applied experience required from a candidate:**
+ Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
+ Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices.
+ Support the creation and maintenance of security design documentation and architecture diagrams.
+ Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
+ Define security requirements and controls based on specific use cases and threat models.
+ Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
+ Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
+ Establish automated processes for vulnerability scanning and remediation
+ Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
+ Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process
+ Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
+ Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
+ Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
**Experiences that are nice to have:**
+ Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
+ Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA,
+ GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
+ Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
**Minimum Requirements:**
+ Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
+ Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
+ Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
+ Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
+ Skilled in working within cross-functional groups.
+ Skilled in performing Risk Assessment and Management plan
+ Skilled in writing design documentation and standard operating procedures.
+ Experience working in an FDA regulated environment is required.
+ Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Strong verbal & written communication skills.
+ Familiarity with Windows OS and cloud-based solutions is required
+ Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
+ Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
**Why Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, **apply today!**
\#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Lead Product Security Engineer (R&D Cytology)
Marlborough, MA jobs
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a Lead Product Security Engineer and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
This position will operate as part of the broader Diagnostics team, which has additional members in San Diego, to create a cohesive cybersecurity strategy for the division.
Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
Participate in continuous improvement of our Secure by Design policies and procedures, ensuring adherence to security standards and best practices.
Support the creation and maintenance of security design documentation and architecture diagrams.
Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
Define security requirements and controls based on specific use cases and threat models.
Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
Establish automated processes for vulnerability scanning and remediation
Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process.
Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
Required Education and Experience:
Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
Skilled in working within cross-functional groups.
Skilled in performing Risk Assessment and Management plan
Skilled in writing design documentation and standard operating procedures.
Experience working in an FDA regulated environment is required.
Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Strong verbal & written communication skills.
Familiarity with Windows OS and cloud-based solutions is required
Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $128,300 to $200,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Auto-ApplyLead Product Security Engineer (R&D Cytology)
Marlborough, MA jobs
Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
**Key responsibilities and applied experience required from a candidate:**
+ Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
+ Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices.
+ Support the creation and maintenance of security design documentation and architecture diagrams.
+ Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
+ Define security requirements and controls based on specific use cases and threat models.
+ Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
+ Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
+ Establish automated processes for vulnerability scanning and remediation
+ Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
+ Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process
+ Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
+ Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
+ Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
**Experiences that are nice to have:**
+ Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
+ Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA,
+ GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
+ Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
**Minimum Requirements:**
+ Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
+ Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
+ Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
+ Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
+ Skilled in working within cross-functional groups.
+ Skilled in performing Risk Assessment and Management plan
+ Skilled in writing design documentation and standard operating procedures.
+ Experience working in an FDA regulated environment is required.
+ Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Strong verbal & written communication skills.
+ Familiarity with Windows OS and cloud-based solutions is required
+ Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
+ Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
**Why Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, **apply today!**
\#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Manufacturing Engineer
Remote
The Role
The Manufacturing Engineer is responsible for developing automated solutions, implementing new processes, optimizing existing processes, automated data collection, and executing the industrial control and programming strategy for GTI's production facilities. This position will work closely with the multiple teams to ensure flawless and quick speed to market. Success is gauged on the ability to deliver quality, detailed, and efficient solutions at scale. The Manufacturing Engineer will play a pivotal strategic role in priority projects from a feasibility standpoint through a full IQ, OQ, PQ validation and hand-off with a technical transfer to the site production team. They work collaboratively with multiple teams to deliver productivity improvements and Continuous Improvement.
Responsibilities
50% travel required
Coordinate the efforts of Engineering and technical resources based on Senior Leadership Priorities and Site 90-day plan priorities.
Work with other departments (i.e. Prod Development, Project Management, Quality, Compliance, Operations, etc.) to integrate new systems.
Dedicate start-up management support for selected complex project integrations.
Ensures constant updates are provided to the VP of Manufacturing on the status of projects and improvement efforts in the facilities.
SME for automated packaging equipment, flow wrappers, beverage line, multi-combi scales, bag filling equipment, integrations, and automation.
Conduct studies, identify problems, recommend alternatives, and implement solutions in coordination with other teams.
Develop and deploy automated solutions for numerous processes to gain efficiency and streamline workflows.
Provide support to Start-up facilities via technical transfer:
Staffing
Equipment layout and requirements
Construction hand off
Regulatory engagement
Best-practice processes
Technical transfer related to equipment
Work with integrators, contractors, and site personnel to bring new functionality online and to troubleshoot issues as they arise.
Work with site maintenance and facilities personnel to develop and execute preventative maintenance plans.
Maintain up to date as-built records and drawings for existing and new deployments.
Integrate existing equipment with live data stream to dashboard with historian, report generation, alarms, notifications, and live visuals for site teams to track daily production.
Other duties as assigned
Qualifications
Bachelor's degree in engineering and 5+ years Operations and Engineering experience in a manufacturing environment.
Proven strategic experience in overseeing all aspects of large-scale manufacturing projects
Knowledgeable of TPM-based continuous improvement methodology
Knowledgeable of Engineering problem solving
Able to diagnose complex technical systems and develop simple human-machine interface and training solutions for optimal operations.
Experience in industrial networking/automation (SCADA-Ignition, ITOT, cyber security), controls experience (PLC - AB, Omron, Schneider, ladder logic \ STX), business and data analytics for manufacturing operations (Power Bi, Tableau,) vision systems, and robotics.
Highly motivated, self-directed, innovative and able to work independently or among teams with keen judgement, common sense and resourcefulness
Adapts and thrives in a demanding, start-up, fast-paced environment
Possesses a high level of critical thinking
Effective time-management skills and ability to multi-task
Ability to work well with others while also completing individually assigned tasks.
Operates with a high level of professionalism and integrity, including dealing with confidential information
Must understand and comply with the rules, regulations, policies, and procedures of GTI
Must have a solid understanding of the Medical Marijuana laws, rules and regulations set forth by the state; a pursuit to further their understanding and knowledge of the industry and the laws.
Safety and Compliance
Be aware of hazards in the workspace.
Retain and understand department specific training.
Report safety incidents/ concerns and comply with follow-up actions.
Be compliant with area safety requirements, state regulations and PPE requirements.
Follow GMP, biosecurity, sanitation or other quality and compliance requirements.
Perform record keeping accurately and completely as directed by a lead or supervisor.
Maintain and calibrate tools, equipment and machinery as directed by a lead or supervisor.
Report and escalate safety & quality concerns.
Working Conditions
While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions.
Must be able to sit and/or stand for extended periods of time while maintaining focus.
Must be able to lift, carry, and balance up to 50 pounds (and up to 100 pounds with assistance) AND must be able to do so with extreme care and caution when working with product.
Ability to work in a fast-paced, changing, and challenging environment
Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil).
Additional Requirements
Must pass any and all required background checks
Must be and remain compliant with all legal or company regulations for working in the industry
Must possess valid driver's license
Must be a minimum of 21 years of age
Must be approved by state badging agency to work in cannabis industry
The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance.
Green Thumb Pay Range$90,000-$110,000 USD
Auto-ApplyStaff Medical Device Engineer
San Diego, CA jobs
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a member of the Advanced Research & Technology (ART) Team you will support the evaluation of new technologies through testing, modeling, analysis, prototyping, and experimentation. Working as a member of a technology team, this engineer will collaborate and communicate with other engineers and scientists on the team as well as interface with technical personnel from other departments and vendors. This position offers a unique opportunity to have significant impact towards defining Dexcom's development roadmap and influencing the lives of millions of people within a small team of engineers.
Where you come in:
Design, setup, plan, and perform electrical, mechanical, or related experiments in the lab
Design, fabricate, document, and troubleshoot new test fixtures and equipment
Improve and/or optimize existing test equipment, fixtures, and methods
Support development of new or improved test methods simulating actual product use conditions
Generate and execute test protocols leveraging statistical best practices, documenting the results
Analyze experimental data to build statistically sound models and develop conclusions
Provide design recommendations while also acknowledging potential tradeoffs of solutions
Build and evaluate prototypes
What makes you successful:
Comfortable working hands-on in a fast-paced environment
Comfortable managing several parallel activities
High Proficiency with engineering software tools for CAD (SolidWorks required)
High Proficiency with statistical analysis (DOE, Gauge R&R, ANOVA, Power and Sample Size)
Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
Strong interpersonal and teamwork skills
Demonstrated written and verbal communication skills
Familiarity with DMAIC problem solving techniques
Familiarity with FEA tools (Abaqus preferred)
Familiarity with JMP or Minitab (JMP preferred)
Familiarity with programming (LabView preferred)
Familiarity with image processing techniques
Familiarity with control systems (actuators, pneumatics, sensors, etc.)
Familiarity operating equipment within a machine shop (Mill, Lathe, etc.)
Experience working within a regulated medical device environment
Proficiency with Microsoft Office Products
Basic skills or knowledge related to product, process, equipment, and fixture design, development and improvement
What you'll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
0-5%
Experience and Education Requirements:
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8- 12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$128,600.00 - $214,400.00
Auto-ApplyStaff Medical Device Engineer
San Diego, CA jobs
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a member of the Advanced Research & Technology (ART) Team you will support the evaluation of new technologies through testing, modeling, analysis, prototyping, and experimentation. Working as a member of a technology team, this engineer will collaborate and communicate with other engineers and scientists on the team as well as interface with technical personnel from other departments and vendors. This position offers a unique opportunity to have significant impact towards defining Dexcom's development roadmap and influencing the lives of millions of people within a small team of engineers.
Where you come in:
* Design, setup, plan, and perform electrical, mechanical, or related experiments in the lab
* Design, fabricate, document, and troubleshoot new test fixtures and equipment
* Improve and/or optimize existing test equipment, fixtures, and methods
* Support development of new or improved test methods simulating actual product use conditions
* Generate and execute test protocols leveraging statistical best practices, documenting the results
* Analyze experimental data to build statistically sound models and develop conclusions
* Provide design recommendations while also acknowledging potential tradeoffs of solutions
* Build and evaluate prototypes
What makes you successful:
* Comfortable working hands-on in a fast-paced environment
* Comfortable managing several parallel activities
* High Proficiency with engineering software tools for CAD (SolidWorks required)
* High Proficiency with statistical analysis (DOE, Gauge R&R, ANOVA, Power and Sample Size)
* Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
* Strong interpersonal and teamwork skills
* Demonstrated written and verbal communication skills
* Familiarity with DMAIC problem solving techniques
* Familiarity with FEA tools (Abaqus preferred)
* Familiarity with JMP or Minitab (JMP preferred)
* Familiarity with programming (LabView preferred)
* Familiarity with image processing techniques
* Familiarity with control systems (actuators, pneumatics, sensors, etc.)
* Familiarity operating equipment within a machine shop (Mill, Lathe, etc.)
* Experience working within a regulated medical device environment
* Proficiency with Microsoft Office Products
* Basic skills or knowledge related to product, process, equipment, and fixture design, development and improvement
What you'll get:
* A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
* A full and comprehensive benefits program.
* Growth opportunities on a global scale.
* Access to career development through in-house learning programs and/or qualified tuition reimbursement.
* An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
* 0-5%
Experience and Education Requirements:
* Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8- 12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$128,600.00 - $214,400.00
Product Engineer, Decorative Plating
Brunswick, OH jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Support Management to Develop and implement sales strategies to achieve revenue goals.
Work together with Sales and Marketing teams to Identify and pursue new business opportunities within the decorative plating and surface treatment market.
Offer technical support and guidance to customers, helping them understand the benefits and applications of our products.
Support Management to Conduct market research to stay informed about industry trends and competitor activities.
Prepare and deliver engaging sales presentations and proposals.
Maintain accurate records of sales activities and customer interactions in CRM systems.
Qualifications:
Proven 3 - 5 years of experience in in technical sales or Field Services Engineering in the Decorative Electroplating Industry.
Bachelor's degree in Engineering, Chemistry, Materials Science, or a related field is a plus for the candidate.
Strong understanding of plating and coating technologies and their applications.
Excellent communication, negotiation, and presentation skills.
Ability to work independently and collaboratively.
Proficiency in Microsoft Office Suite, knowledge in CRM Software is a plus.
Willingness to travel as needed.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
SurTec Inc.
Auto-ApplyProduct Development Engineer II
Miami, FL jobs
Job DescriptionDescription:
Job purpose
Under supervision of the Vice President of R&D, the Product Development Engineer II is responsible for researching and developing new production processes or products from bank human tissue, making modifications to existing manufacturing systems and processes, and to improve the overall efficiency of the R&D department.
Duties and responsibilities
Evaluate the feasibility of selected concepts to meet the clinical and customer needs.
Generate design history documents in compliance with regulating bodies.
Expert ability to design research approaches and design of experiments for assigned projects.
Identify needs and goals for a new products and processes, including defining specifications and tolerances captured in user and engineering requirements.
Coordinating with marketing and material suppliers to evaluate market needs and identify existing competition.
Coordinating with finance to develop timelines and project plans and cost estimates of new products/processes developed, and to appraise management of performance against plan.
Plan and organize engineering runs, including writing of validation protocols and testing instructions, and performing trials and analyzing data.
Works specifically to develop new tissue products or processes and ensure proper technology transfer occurs, including identification of material and service suppliers, writing the necessary work instructions and SOPs, ensuring the final product/process meets regulatory compliance, and product safety.
Can provide mentorship to junior scientists and engineers, including students and interns, to promote skills and growth.
Other duties as assigned.
Requirements:
Qualifications
BS, Advanced degree (Master's, PhD) a plus, in engineering. Relevant experience in product development preferred.
CTBS certified (or certified within two years of employment)
Thorough understanding of design control processes and requirements.
Strong knowledge of AATB and FDA regulations as they pertain to human tissue banks.
Excellent analytical, problem solving, and investigative skills.
Demonstrates excellent communication (both oral and written) skills.
Working conditions
Job requires working in office, laboratory, and manufacturing environments. There will be evening and weekend work.
Physical requirements
Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing research plans.
Direct reports
N/A
Product Development Engineer II
Miami, FL jobs
Job purpose
Under supervision of the Vice President of R&D, the Product Development Engineer II is responsible for researching and developing new production processes or products from bank human tissue, making modifications to existing manufacturing systems and processes, and to improve the overall efficiency of the R&D department.
Duties and responsibilities
Evaluate the feasibility of selected concepts to meet the clinical and customer needs.
Generate design history documents in compliance with regulating bodies.
Expert ability to design research approaches and design of experiments for assigned projects.
Identify needs and goals for a new products and processes, including defining specifications and tolerances captured in user and engineering requirements.
Coordinating with marketing and material suppliers to evaluate market needs and identify existing competition.
Coordinating with finance to develop timelines and project plans and cost estimates of new products/processes developed, and to appraise management of performance against plan.
Plan and organize engineering runs, including writing of validation protocols and testing instructions, and performing trials and analyzing data.
Works specifically to develop new tissue products or processes and ensure proper technology transfer occurs, including identification of material and service suppliers, writing the necessary work instructions and SOPs, ensuring the final product/process meets regulatory compliance, and product safety.
Can provide mentorship to junior scientists and engineers, including students and interns, to promote skills and growth.
Other duties as assigned.
Requirements
Qualifications
BS, Advanced degree (Master's, PhD) a plus, in engineering. Relevant experience in product development preferred.
CTBS certified (or certified within two years of employment)
Thorough understanding of design control processes and requirements.
Strong knowledge of AATB and FDA regulations as they pertain to human tissue banks.
Excellent analytical, problem solving, and investigative skills.
Demonstrates excellent communication (both oral and written) skills.
Working conditions
Job requires working in office, laboratory, and manufacturing environments. There will be evening and weekend work.
Physical requirements
Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing research plans.
Direct reports
N/A
Product Regulatory Engineer - Lead Biostatistician
Waukesha, WI jobs
The Product Regulatory Engineer - Lead Biostatistician is responsible for activities contributing to regulatory submissions for AI-driven medical software and devices within the General Imaging and Primary Care Business. This position bridges engineering, regulatory affairs, and biostatistics, ensuring that validation studies, data analysis, and regulatory documentation meet the highest standards required by global agencies (FDA, NMPA, etc.). The ideal candidate will leverage their biostatistics expertise to design, analyze, and justify validation datasets and metrics, while streamlining regulatory processes for the product engineering team.
Job Description
Roles and Responsibilities
Regulatory Study Design & Data Management
* Define validation dataset requirements (size, demographics, sites) in compliance with regulatory guidance.
* Acquire, clean, and document datasets for regulatory validation, ensuring data integrity and traceability.
* Design and oversee regulatory test plans and procedures, including dry runs and iterative improvements.
* Organize and index validation data and metadata for efficient analysis and reporting.
Statistical Analysis
* Perform advanced statistical analyses (e.g., power calculations, Wilcoxon Ranked Sign Test, Bland-Altman etc.) to justify dataset size and model performance.
* Generate and interpret statistics from reader studies and other validation experiments.
* Provide statistical reasoning behind Reader studies and documentation for regulatory submissions, addressing agency feedback.
Regulatory Documentation & Submission
* Write and review regulatory reports (e.g., FDA 510k, NMPA) with a focus on statistical rigor and clarity.
* Collaborate with engineering and regulatory affairs to ensure alignment with the latest regulatory requirements and best practices.
* Respond to regulatory agency feedback, providing statistical and technical justifications as needed.
Project Management & Cross-functional Collaboration
* Coordinate with clinical experts, data annotators, and arbitrators to ensure validation studies meet regulatory standards.
* Track regulatory landscape changes and update processes accordingly.
* Support the creation and standardization of regulatory processes and documentation for future teams.
Required Qualifications
* Advanced degree (MS/PhD) in Biostatistics, Statistics, Biomedical Engineering, or related field.
* Experience in regulatory submissions for medical devices or software (FDA, NMPA, or similar).
* Strong proficiency in statistical analysis, experimental design, and data management.
* Familiarity with AI/ML model validation and performance metrics.
* Excellent written and verbal communication skills, especially in technical and regulatory documentation.
* Ability to manage multiple projects and context-switch efficiently in a fast-paced environment.
* Experience working with cross-functional teams (engineering, clinical, regulatory).
Desired Characteristics
* Experience with regulatory test planning and reader studies.
* Knowledge of medical imaging data formats and annotation tools (e.g., V7).
* Project management experience in a regulated environment.
* Familiarity with regulatory feedback cycles and deficiency response processes.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Procurement Engineering Leader - MR / New Product Introduction Sourcing
Aurora, OH jobs
Procurement Engineering Leader is focused on the successful launch of new products- Coil within our MR modality. The NPI Sourcing professional is responsible for providing a supply base that provides a competitive advantage for GE Healthcare in order to support the on time and to budget delivery of NPI projects. This is a hybrid role, residing in Aurora Cleveland (OH01-01-Cleveland-Aurora Coils)
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities:
* Sourcing professional focus on provide value to product development through leveraging supplier capabilities and technologies during product design.
* Select strategic suppliers for new products and prepare suppliers to deliver targeted requirements such as quality, fulfillment and cost
* Collaborate with engineers, project managers, the supplier management team, supply chain team and others across the business to achieve results
* Lead sourcing initiatives early in the product development phase keeping in line with our product simplification and platforming goals
* Meet cost targets
* Ensure technology matches occur between supply partners, engineering and manufacturing so that product and factory fulfillment requirements are met
* Be highly engaged in technical design reviews, considering supplier expertise and innovation in component design and specifications
* De-risk supplier base by identifying the risk and executing mitigation plans, in partnership with business leaders
* Ensure NPI teams utilize preferred suppliers as identified in Global Healthcare sourcing strategies.
* Understand and convey the technical needs of MR Engineering to Global Sourcing personnel during category strategy development.
* Development and deployment of MR's first Early Supplier Involvement (ESI) program
* Supporting our Supplier Quality Program, ensuring supplier compliance with FDA, EHS, transportation and other regulatory and reputation requirements
Required Qualifications:
* Bachelor's degree
* Minimum 5 years Sourcing (Procurement), Engineering or Supply Chain Management Experience
Desired Qualifications:
* Degree in Electrical Engineering is preferred
* Degree in Mechanical Engineering
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-Hybrid
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Field Application Engineer
San Jose, CA jobs
Responsible for supporting the adoption and deployment of comapny's cutting-edge CXL-based computational memory solutions. Major responsibilities include engaging with customers and partners to understand their technical requirements and ensuring seamless integration and
exceptional performance of company's products.
Key Responsibilities
- Customer/Partner Engagement CPU and Server Validation Process management
o Serve as the primary technical contact for customers, developing and executing
comprehensive device validation plans for company's CXL computational memory
solutions.
o Collaborate with customers to understand their system architectures, workloads,
and challenges, delivering tailored recommendations for seamless integration and
optimal performance.
o Manage test equipment setup, experimental planning, results analysis, and the end-
to-end validation process at customer sites, ensuring rapid adoption and high
reliability of company's devices.
- Product Support and Training
o Conduct system-level debugging, performance tuning, and root cause analysis for
customer-reported issues.
o Develop and deliver technical presentations, training sessions, and documentation to
help customers effectively utilize company's computational memory.
o Assist in the creation of application notes, user guides, and best practices
documentation.
- Cross-functional Leadership and Technical Sensing
o Work closely with company's engineering and product development teams to provide
feedback on customer requirements, feature requests, and potential product
improvements.
o Partner with the marketing and business development teams to support go-to-
market strategies, including technical demos and proof-of-concept projects.
o Stay updated on emerging trends in computing systems (e.g. CXL, CPU, memory, and
near data processing) technologies to proactively address market demands and
challenges.
Key Requirement
- Minimum Qualifications:
o Bachelors or Masters degree in Engineering, Computer Science, or a related field
(or equivalent experience).
o At least 10 years of experience in technical and commercial roles, preferably within
CXL, Near-Data Processing, AI, or memory industries.
o Demonstrated ability to thrive in team-oriented environments while also working
independently, especially in high-pressure or ambiguous situations.
o Exceptional leadership, communication (both written and oral), and interpersonal
skills.
o Strong organizational and analytical abilities.
o Effective problem-solving and issue resolution skills.
o Willingness and ability to travel regularly to South Korea and occasionally to other
countries.
- Preferred Qualifications:
o Experience in field application engineering, technical marketing, or technical
specialist roles.
o Comprehensive knowledge of both hardware and software in AI, including
technical, commercial, and product/application expertise.
Associate Principal IT Product Lead - Data Engineering & Architecture
Alameda, CA jobs
SUMMARY/JOB PURPOSE:
The Associate Principal IT Product Lead - Data Engineering and Architecture will oversee Data Strategy, Architecture, and Engineering, key to Exelixis's success and ambition in launching innovative medicines to patients. This role drives strategy, execution, and operational excellence of the data ecosystem, aligning with business goals, data governance, and value delivery. Operating within a product-centric operating model, they will define roadmaps, foster collaboration, and lead agile teams to deliver impactful solutions that accelerate drug discovery, development, and commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Product Strategy & Roadmap (Product-Centric Focus):
Support the development and execution of the vision, strategy, and roadmap for Clinical and Operational data engineering and governance.
Partner with senior product leads and business stakeholders (e.g., R&D, Clinical, Supply Chain, G&A,) to gather insights, understand user needs, and translate them into clear product requirements and user stories.
Design and implement scalable data architectures using AWS, Databricks, and modern patterns like data mesh and Lakehouse.
Contribute to market research, competitive analysis, and technology assessments to inform product planning and identify innovation opportunities.
Evaluate business impact, technical feasibility, compliance needs, and resource constraints to assist in prioritizing product initiatives.
Collaborate with engineering and data governance teams to ensure data architecture follows FAIR principles, is secure, and meets enterprise standards.
Product Development & Delivery (Agile/Product Team Leadership):
Support the Principal Product Lead in mentoring Business Analysts and other team members, encouraging a culture of ownership, innovation, and continuous improvement.
Contribute to managing the product lifecycle from ideation through launch and post-launch optimization, applying Agile methodologies (e.g., Scrum, Kanban) to ensure efficient delivery.
Assist in defining clear user stories, acceptance criteria, and product specifications that align with the product vision and business objectives.
Collaborate with engineering, architecture, and quality assurance teams to ensure the timely delivery of scalable, secure, high-quality, and governed data products.
Coordinate with external vendors and service providers to support alignment on product roadmaps and delivery operations.
Promote user-centric design by incorporating user research, usability testing, and feedback into product enhancements.
Translate business needs into scalable data solutions across clinical, supply chain, and operations domains.
Implement data governance frameworks for quality, lineage, and lifecycle management.
Stakeholder Management & Cross-Functional Collaboration:
Act as a key liaison between IT and business functions, helping to translate technical concepts into business language and vice versa.
Build collaborative relationships with stakeholders to support alignment of product vision, priorities, and outcomes.
Facilitate communication and coordination across product, business, and IT teams to support effective decision-making.
Represent the product team in cross-functional discussions and contribute to strategic initiatives as needed.
Operational Excellence, Quality & Compliance:
Support efforts to maintain the operational stability, performance, and security of data solutions in collaboration with IT operations and infrastructure teams.
Assist in managing vendor relationships and third-party software solutions that support the data and analytics portfolio.
Help ensure compliance with regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality and security standards across product releases.
Contribute to quality assurance processes to ensure product releases meet defined standards.
Actively contribute to the Implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability.
Track and report on key performance indicators (KPIs) to assess product success, adoption, and business impact, and support continuous improvement efforts.
SUPERVISORY RESPONSIBILITIES:
No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
Bachelor's degree in related discipline and 11 years of related experience; or
Master's degree in mathematics or statistics or engineering, and 9 years of related experience.
PhD degree in a related discipline and 5 years of related experience; or
Equivalent combination of education and experience.
Experience/The Ideal Candidate will have:
Minimum of 6 years of experience supporting Enterprise IT enabling business functions.
Minimum of 8+ years of progressive experience in IT, with at least 6+ years in a leadership role focused on data architecture and engineering in a life science or pharmaceutical industry.
Proven experience leading product development teams in an agile/product-centric operating model is essential.
Strong understanding of the drug discovery or clinical development, or commercialization lifecycle within a pharmaceutical or biotechnology company.
Deep understanding of clinical and operational data in a life sciences or Pharma company, including experience creating physical and logical data models for analytics and data science teams that follow data standards.
Extensive experience in creating resilient data architectures on cloud platforms like AWS and Azure, integrating advanced data management solutions such as Databricks and Snowflake.
Experience with regulatory frameworks and compliance in a GxP environment.
Knowledge / Skills:
Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams.
Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making.
Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management.
Solid technical acumen with the ability to understand complex IT architectures and development processes.
Apply hands-on expertise with tools like Databricks, DBT, Glue, Kafka, Airflow, S3, Delta Lake, Redshift, Unity Catalog, and Atlan.
Develop with Spark, Python, SQL, and REST APIs using cloud-native services.
Ability to manage multiple priorities in a fast-paced, dynamic environment.
Occasional travel may be required to other company sites, conferences, or vendor locations.
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $167,000 - $237,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyMedical Device Engineer
Austell, GA jobs
Job Details Experienced AUSTELL, GA Full Time 4 Year Degree None DayDescription
We are seeking a Medical Device Engineer with direct, hands-on experience in Class I and Class II medical device development and sustaining engineering. This role is critical to maintaining the safety, compliance, and performance of our existing product portfolio while contributing to early-stage innovation and concept development.
The ideal candidate will have a minimum of 3 years of industry experience in a regulated medical device environment, with a strong foundation in design controls, risk management, and supplier collaboration. This is not an entry-level role.
What Makes This Role Unique
Be the technical steward for marketed products, ensuring ongoing compliance with FDA and ISO standards.
Influence future product directions through early-stage concept development and unmet need identification.
Collaborate with external consultants and global suppliers, managing deliverables and ensuring alignment with internal standards.
Support internal capability building, including design control education and process improvement.
Key Responsibilities
Lead sustaining engineering activities for Class I and II medical devices.
Remediate and maintain risk management files in accordance with ISO 14971 and FDA 21 CFR Part 820.
Develop and maintain product specifications, technical documentation, and design history files.
Review and manage engineering change requests (ECRs/ECOs).
Collaborate with suppliers to ensure design and quality alignment.
Manage and coordinate work with external consultants and contractors.
Support and educate teams on design control processes.
Develop, execute, and review testing protocols, validation plans, and statistical sampling plans.
Contribute to early-stage product development, including concept creation and feasibility assessments.
Qualifications
Required Qualifications
Minimum 3 years of experience in medical device engineering, specifically with Class I and/or Class II devices.
At least 3 years of hands-on experience in product development, including concept creation, design iteration, and documentation within a regulated medical device environment.
Proven experience in design control, risk management, and sustaining engineering.
Strong knowledge of ISO 13485, ISO 14971, and FDA QSR (21 CFR Part 820).
Experience with test method development, validation, statistical analysis, and sampling plans.
Demonstrated ability to manage contractors and suppliers effectively.
Excellent written and verbal communication skills.
Ability to work cross-functionally in a compliance-driven environment.
Preferred Qualifications
Experience with human factors, usability engineering, and ergonomics.
Familiarity with early-stage product development and innovation planning.
Advanced degree in engineering or related field is a plus.