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Failure Analysis Engineer jobs at Insulet

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  • Associate Failure Analysis Engineer - Acton, Mass (Onsite)

    Insulet 4.7company rating

    Failure analysis engineer job at Insulet

    The Global Product Monitoring Associate Failure Analysis Engineer plays an integral role in Insulet's Quality Department as a hands-on engineer conducting post market investigations of FDA approved medical devices. The role is responsible for conducting detailed failure analyses of returned products to identify root cases and support continuous improvement. Success in this role requires strong analytical skills, attention to detail, ability to collaborate effectively across cross functional teams, and drive to accomplish departmental and company goals. Responsibilities: Conduct product testing and failure analysis to determine root cause of post-market issues. Perform investigation triage and deep-dive analyses to develop and validate failure hypotheses. Review Device History Records (DHRs), Lot Acceptance Records, and other quality documentation to support investigations. Prepare clear, timely, and compliant investigation reports that communicate findings and support post-market surveillance and vigilance activities. Maintain accurate and complete quality records-including documentation for training, audits, and investigation -in alignment with internal procedures and regulatory standards. Support regulatory inspections and internal audits (e.g., FDA, ISO 13485) by maintaining a clean, safe, and organized lab environment, ensuring training records are current, and assisting with documentation retrieval, demonstrations, or other inspection needs. Partner with Engineering, Quality, and other cross-functional teams to implement and maintain inspection and testing procedures, fostering open communication and shared problem-solving. Support trending and data analysis of complaint and nonconformance data to identify systemic issues. Support troubleshooting of new or emerging failure modes and drive risk, design, or process improvements through escalation and user feedback. Participate in continuous improvement projects focused on increased quality, process efficiency, and site safety. Perform other duties as assigned. Education and Experience: Bachelor's Degree in an engineering or scientific discipline, or a minimum of 2 years of experience in an engineering or technical role. Preferred Skills and Competencies: Working knowledge of engineering principles and scientific methods. Ability to follow written and verbal directions and procedures. Accountable and dependable, with strong organizational skills, the ability to prioritize effectively, and a commitment to follow through on responsibilities. Proficiency in Microsoft applications (Outlook, Teams, PowerPoint, Excel). Strong analytical and problem-solving skills; familiarity with root cause analysis tools (e.g., 5 Whys, Fault Tree) and quality methodologies (e.g., Lean Six Sigma, ASQ). Experience in a regulated environment (e.g., medical device, biohazard lab). Collaborative, innovative, and growth-minded team player who values diverse perspectives, contributes to a positive and inclusive culture, and communicates openly to drive continuous improvement. Preferred 2 years in a quality-related function. Familiarity with data analysis tools (e.g., Excel, Minitab, JMP) is a plus. Programming experience (Python, R, C++) is a plus. Physical Requirements (if applicable): Sitting 70%, Standing 30% Frequent lifting Occasional ( Ability to operate basic hand tools NOTE: This position requires on-site working (requires on-site office/plant/lab work). Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $31.00 - $46.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)
    $31-46 hourly Auto-Apply 18d ago
  • Staff Manufacturing Engineer (Onsite)

    Insulet 4.7company rating

    Failure analysis engineer job at Insulet

    The Staff Manufacturing Engineer is a critical member of the plant engineering and operation teams. The Staff Manufacturing Engineer serves as one of the leaders of the technical community, working effectively and collaboratively with all technical disciplines and functions, both internally and externally. This role is responsible for standardizing the manufacturing process, anticipating bottlenecks to capacity, optimizing maintenance, and general continuous improvement of the site. The successful candidate will have strong structured problem-solving skills, understand the complex component and machine interactions and be comfortable working hands-on with automation machinery. The Acton site is a global business HQ and product development site with all commercial, business functions and manufacturing co-located with all technical disciplines. This offers a broad range of career and experience building opportunities. Responsibilities: Accountable to driving maintenance process improvements in support of Insulet's primary manufacturing objectives: Safety, Quality, Delivery, Cost Autonomously interprets data to drive plant decision making and prioritization of reliability efforts. Plan, execute, and manage efficiency improvement projects. Develop and implement process controls to stabilize and sustain equipment reliability. Develop and deliver training to build the capability of the plant engineering and maintenance teams as part of continuous improvement efforts. Maintain direct hands-on interaction with the manufacturing equipment including station set-up and troubleshooting using hand tools, measurement tools, machine documents, specialty gages, and high-speed filming equipment. Provide input and support for technology transfer and equipment design reviews. Perform other duties as required. Behavioral Competencies: Decision Making - has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions. Communication Skills - Conveys information effectively, actively listens, resolves conflict constructively. Work Organization - Takes a structured, economical approach to resources including time, people, money, and equipment. Initiative - Makes decisions and takes actions appropriately. Willing to take risks as circumstances require. Planning Skills - Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals. Perseverance - Achieves objectives by overcoming difficulties through tenacity and resilience. Education and Experience: Minimum Requirements: Bachelor of science in Mechanical Engineering or related field. 8+ years of experience working directly on automated manufacturing equipment. Preferred Skills and Competencies: Hands-on experience in setup and operation of automated production equipment Advanced proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics tools Demonstrated success using problem solving methodologies such as A3, PDCA, DMAIC, etc. Ability to read and understand technical drawings, schematics, and manuals. Hands-on technical ability with assembly methodologies including locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc. Proficiency using Solid Works, AutoCAD, Microsoft Suite: Word, Excel, etc. Technical knowledge of cam driven linkages, discrete component assembly, and automation Familiarity working within cGMP guidelines and ISO 13485/21FDA820 regulations. Experience working in a regulated industry. Have strong interpersonal and communication skills. Excellent attention to detail, organizational skills, and rigorous process discipline Thirst for knowledge and intense curiosity. NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $113,550.00 - $170,325.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)
    $113.6k-170.3k yearly Auto-Apply 3d ago
  • Process Engineer

    Freudenberg Group 4.3company rating

    Necedah, WI jobs

    * Produces new products, material, applications, process ideas, approaches, insights, and designs * Creates innovative and profitable products and processes, which meet and anticipate customer needs * Plans activities and projects in alignment with the site or Division's strategic goals * Conducts feasibility studies to validate concepts and construct specifications in order to offer recommendations for improvement opportunities * Demonstrates financial awareness with respect to product, process design and, if necessary, vendor selection * Analyzes data inputs to identify patterns and relationships to determine appropriate engineering methodologies Qualificationsarrow_right * Bachelor's degree in Mechanical, Materials, Industrial Engineering, or related field. * 3-5+ years of experience in process engineering, product development, or manufacturing engineering in a production environment. * Demonstrated track record of taking concepts through feasibility, specification development, validation, and launch. * Experience analyzing complex datasets to inform engineering methodologies and decision-making. * Strong proficiency in process design, scale-up, and optimization (pilot-to-production). * Statistical analysis and data-driven decision-making (SPC, DOE, regression analysis). * Proficient with CAD/CAE tools (e.g., SolidWorks, AutoCAD) and data analysis tools (Excel, Minitab, or similar). * Communication & Collaboration: Communicates clearly and concisely, while engaging proactively with colleagues at all levels of the organization. * Value for Customers: Anticipates, understands and meets internal/external customers' needs and expectations. Develops solutions based on a customer centric approach. * Innovation: Drives and supports innovative ideas, while taking informed risks to seek and develop new or improved solutions. * Drive & Execution: Proactively identifies what needs to be done and takes action. Explores new ways and pursues new opportunities. 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.
    $57k-72k yearly est. 8d ago
  • Process Engineer

    Plantible Foods 3.8company rating

    Texas jobs

    How you will contribute: We are seeking a Process Engineer who combines analytical rigor with hands-on curiosity - someone who loves data as much as they love getting their boots dirty. Based in Austin but frequently on site at our Ranchito facility, you will lead projects that optimize throughput, drive yield improvements, and scale technologies from R&D into full commercial operation. This role is ideal for someone who thrives in a fast-paced, high-impact startup environment-working shoulder to shoulder with operators, scientists, and engineers to continuously improve our production process from cultivation to packaging.. What you will be working on: Process Optimization & Continuous Improvement: Analyze plant and process data to identify inefficiencies in yield, throughput, and resource utilization. Design, implement, and validate process improvements in collaboration with operations, maintenance, and controls teams. Develop models, SOPs, and documentation to institutionalize process knowledge. Champion a data-driven, Kaizen mindset across the plant. Technology Transfer Translate R&D findings into robust, scalable manufacturing processes. Develop detailed process documentation including PFDs, P&IDs, and mass/energy balances. Collaborate closely with pilot and R&D teams to design and execute scale-up trials. Support commissioning, validation, and troubleshooting of new process lines and equipment. Capital & Engineering Projects Scope and execute CAPEX projects that enhance safety, reliability, and performance. Support the design and implementation of automation and control improvements. What your week will look like: Work closely with the Engineering, Operations and Research teams to optimize current processes and scale up new developments. Spend time at the commercial facility working on process improvements & new engineering developments to successful tech transfers. Develop and communicate process designs using process flow diagrams, P&IDs, process narratives, and volume and mass balances. Monitor operations and project progression, resolve any issues that arise, and coordinate team activities to maintain the approved schedule. Update management team and other project engineers on project progress and requirements regularly in written reports and presentations. Control project pace and budget and manage project changes as needed. What you bring to Plantible: B.S. or M.S. in Process, Chemical, Mechanical, or Bioprocess Engineering (or related discipline). 3-7 years of hands-on experience in food, biotech, or ingredient manufacturing; preferably in protein or fermentation systems. Proven ability to lead process optimization and scale-up initiatives. Familiarity with PFD/P&ID drafting, H&M balances, and process simulation tools (e.g., Aspen, SuperPro, AutoCAD, or equivalent). Understanding of sanitary design, food safety (HACCP, FSMA), and equipment standards (USDA, FDA). Strong communication skills; comfortable bridging R&D and plant operations. A proactive, “get-it-done” attitude with the flexibility to work on-site at Ranchito as projects demand. Choose Plantible Foods Joining Plantible means contributing to a sustainable future for all. We are a venture backed startup that is both spreading happiness amongst our employees and to current and future generations. We believe diversity creates uniqueness. Our team is composed of highly talented people with different interests and hobbies, which makes for a rich working environment. At Plantible we are continually working on our offerings to foster the best team. Check it out! Competitive health and wellness benefits Medical, Dental and Vision Insurance Discretionary Unlimited PTO Program Paid Holidays 401k Program Career Stipend Career development and growth opportunities Working in a rapidly growing, flexible and entrepreneurial environment Team building and company-wide events Financial support with your relocation, if necessary, ensuring a smooth transition Plantible Foods is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, veteran status, marital status, gender identity, sexual orientation, national origin, liability for military service, or any other characteristic protected by applicable federal, state, or local law. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. Plantible Foods reserves the right to defer or close a vacancy at any time. If you feel your skill set does not meet all listed qualifications for the role, we still encourage you to apply. As we continue to grow our company, we are seeking a range of candidates and would gladly consider you for other current or upcoming roles that may be a fit!
    $76k-102k yearly est. 60d+ ago
  • Future Opportunity - Process Engineer (Summer 2026 New Grad)

    Ten Ten 4.1company rating

    Houston, TX jobs

    About Technip Energies At Technip Energies, we are more than just a leading engineering and technology company; we are pioneers committed to shaping a sustainable future. With over 65 years of experience and 17,000+ talented professionals worldwide, we deliver innovative solutions to real-world energy challenges. We believe in the power of collaboration, diversity, and an inclusive culture where your well-being is a top priority. Join us on a one-of-a-kind journey where you can take pride in Being Part of the Solution for the benefit of our planet, people, and communities. If you share our vision of driving the transition to a low-carbon future and are eager to develop your skills for tomorrow, then this could be the perfect opportunity for you. We are currently seeking a Process Engineer I to join our Process & Technology team based in Houston, TX Please note this is a Pipeline requisition created for future hiring in Summer 2026. About the Job Delivery of technically & qualitatively high-level process engineering design within proposals, studies, projects execution & operations, as part of a study and/or project team, in accordance with design & engineering standards & procedures, schedules and budget, with a continuous concern for quality standards, targets and customer satisfaction. We offer you not only a job, but an inspiring journey in a truly global environment where you team up to break boundaries thanks to the innovation, creativity, resilience and team spirit expressed by our people. Responsibilities: Assists in the analyzing of project specifications, tender and proposals requirements. Contributes to the development of design parameters and methodologies. Participates in the preparation of technically correct, safe, environmentally friendly, cost & time effective discipline engineering analysis and solutions for approval. Provides support to all project activities, from engineering to start-up, as required. Interfaces with other process engineering disciplines and design team(s). Assists in development of a process knowledge databases for studies, projects and/or operations (capturing and reporting events & experiences within studies, projects & operations and writing of technical notes). May participate in pre-commissioning, commissioning, and start-up. Reports own activities within studies, projects and/or operations management. Participate in our Global Graduate Program: This graduate program gives you unique access to a diverse range of technologies and initiatives, offers you global exposure, a chance to connect with Technip Energies' leaders, and allows you to create a network of peers who are passionate about what they do: engineering a sustainable future. Through a tailored development and learning journey: we provide the tools and resources, and opportunities you need to thrive and have a direct impact. At Technip Energies we need to you to be part of the solution. About You We'd love to hear from you if your profile meets the following essential requirements: Qualifications: Minimum of a Bachelor's degree in Chemical Engineering First experience in process design / domain of specialty Theorical knowledge of process design/domain of specialty methods and tools Fluency in professional English Level of experience: Basic knowledge of theories, practices and procedures Less than 2 years of experience within process design / domain of specialty (please note internships and co-ops are not counted towards experience) Organizes own work to meet deadlines set by others. Applicants must be authorized to work for any employer in the United States. Employment is contingent upon proof of eligibility to work in the United States. #LI-RH1
    $76k-102k yearly est. Auto-Apply 60d+ ago
  • Process Engineer I

    Vivex Biologics 3.7company rating

    Miami, FL jobs

    Job purpose The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above. Duties and responsibilities Plan and execute process optimization, equipment qualification, and process validation or process qualification projects. Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements. Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports. Lead efforts to solve problems using formal problem resolution techniques and root cause analysis. Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan. Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team. Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards. Assess processes, take measurements, and interpret data. Develop and monitor process and equipment metrics to use for optimization analysis. Comply with FDA and AATB tissue banking standards. Other duties as assigned. Requirements Qualifications Qualifications include: BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master's) a plus. 1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred. Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills. Ability to effectively communicate with multidisciplinary teams. Excellent technical skills and writing. Strong knowledge of LEAN manufacturing principles preferred. Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred. Proficient in project planning software. Microsoft Project preferred. CTBS certified (or certified within two years of employment). Strong work ethics. Working conditions Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. Physical requirements The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans. Direct reports No direct reports
    $64k-86k yearly est. 60d+ ago
  • Process Engineer II

    Vivex Biologics 3.7company rating

    Miami, FL jobs

    The Process Engineer II is responsible for ensuring the organization is compliant with all applicable regulations and standards in the areas of process validations. In addition, this position leads process change and improvement throughout the different areas of the company, including manufacturing. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to the manufacturing floor. The Process Engineer II makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above. Requirements Duties and responsibilities Provide backup support to the Director Research and Development Operations, as needed. Perform critical review of Process Engineer I project plans and related documents to ensure implementation is accurate and timely. Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against plan. Perform data and technical presentation reviews as needed. Understand and apply the applicable regulations and standards for equipment qualification and process validation to ensure compliance. Statistical and analytical methods to understand processes. Use LEAN Manufacturing principles to analyze and make recommendations for process optimization and implementation. Work with other department heads or designees on projects as delineated on project plans to ensure timely completion of projects. Develop equipment and process validation protocols (IQ, OQ, PQ) and reports as needed. Lead and perform equipment qualifications and process validations as needed. Develop and monitor process and equipment metrics to use for optimization analysis. Develop and implement solutions with minimal supervision. Comply with FDA and AATB tissue banking standards. Other duties as assigned. Qualifications BS in Biomedical, Mechanical, Industrial Engineering or other applicable engineering discipline. Advanced degree (Master's) a plus. A minimum of 3 years of experience in Tissue Banking, Device, Biologics, or pharmaceutical industry in a relevant engineering role. Leadership experience preferred. Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills. Ability to effectively communicate with multidisciplinary teams. Excellent technical skills and writing. Strong knowledge of LEAN manufacturing principles preferred. Strong knowledge of 21CFR 1271 regulations and AATB guidelines. Highly proficient in project planning software. Microsoft Project preferred. CTBS certified (or certified within two years of employment). Strong work ethics. Working conditions Job requires working in office. Must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. 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 engineering plans. Direct reports Intern Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training. Vivex Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
    $64k-86k yearly est. 60d+ ago
  • Production Process Engineer

    Cook Medical 4.4company rating

    Poway, CA jobs

    Accountable for applying engineering techniques to the Production Operation in support of the company's strategic plan. Recommends manufacturing equipment and processes designed to be efficient, cost-effective, and to promote quality and reliability. Assesses current equipment and processes, and makes recommendations for changes. Helps to troubleshoot and repair equipment. Performs process engineering assignments (Equipment, Logistics, Operator Training, etc.) with detailed project plans and timelines. Work from generally stated objectives and guide the direction of assigned projects. Communicates detailed project status to all levels. Pay Range: $90,000 - 105,000/yr Responsibilities * Evaluate existing Production processes, develop, recommend, document and implement new processes to improve quality, reduce costs and reduce cycle time. * Assess machine capability and capacity * Perform validation studies, with appropriate specified protocols * Provide training to other personnel (production and engineering) as needed * Perform customer Contract Review to ensure compliance to process capabilities * Evaluate and Certify new Production equipment * Investigate and solve technical problems as they occur Qualifications Education and Experience: * Minimum 2 years exempt-level engineering work experience in a non-assembly, non-automated manufacturing environment with a focus on manufacturing process improvement and hands-on experience with troubleshooting manufacturing equipment and processes. * B.S. in Mechanical Engineering. Mechanical Engineering strongly preferred other engineering disciplines considered. * Work experience may substitute for educational requirement, per K-Tube equivalencies chart. Job Knowledge, Skills and Abilities: * Solid understanding of the structure and properties of metals * Analytical thinking and problem solving skills. * Ability to apply fundamental Lean and Engineering concepts to real world activities and problems. * Good understanding of measuring systems, essentials of non-destructive testing, and sampling plans. * Prefer multi-disciplinary engineering experience, demonstrating the ability to apply engineering principles to explain observed system behavior. * Prefer experience with database structures, ERP, 3D modeling, and/or programmable controllers. * Must have good communication skills, both written and spoken. * Must be proficient with MS Word, Excel, Power Point, Outlook and SolidWorks Physical Requirements: * Must be able to lift up to 25 pounds * Light to moderate physical effort required * Regularly required to sit or stand, reach and move about the facility Work Environment: * Work performed in both a manufacturing and office environment * Exposure to metals, lubricants, solvents, electrolytes and other hazardous materials Personal Protective Equipment: * Safety glasses and safety shoes are required * Other personal safety equipment required as listed in SDS depending on task may include safety goggles, ear protection, full - face shield, apron, arm guards, rubber boots and gloves Position Type: Hybrid - typically requires 3 days per week in the office and additional days as necessary Status: Full Time/Exempt Reports to: Operations Manager We offer US based employees: * Competitive base and bonus * Medical, dental, and vision insurance * 401(k) plan with ER match - 100% on first 4% contributed, profit sharing plan with 6 year vesting schedule * 15 days of PTO * 8 paid holidays * Office closure between December 23 - January 1 * 5 paid sick days * Paid parental leave * Tuition Assistance Qualified candidates must be legally authorized to be employed in the United States. K-Tube does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.
    $90k-105k yearly 60d+ ago
  • Process Engineer

    Serenity Solution 3.7company rating

    Niagara Falls, NY jobs

    We are seeking a charismatic and dynamic engineer to join our technical team at the Niagara Falls Ceramics Plant! The engineer provides engineering and consulting support to maintain and develop products or processes and manages technical information flow for the same. Primary accountability is to support both commercial and manufacturing in the Armor product line. This includes active contact with the customer regarding product requirements and translation of these requirements into product definition. Takes into account effective use of materials and resources and recommends changes to product specifications as necessary. The engineer will provide technical service support to the sales organization to solve customer needs and product or processes problems for the purpose of maintaining and increasing sales. The engineer works within an engineering group that provides technical support and development throughout the business organization. The engineer is expected to take advice from and give advice to the senior technical and production managers, as well as function as technical expert for associates within operations, as well as the commercial team. The engineer will serve as the technical team leader for the specified product line. Product Applications may be found in multiple arenas, some of which are untouched and, in their infancy, developing and utilizing Armor products. The incumbent must continue to develop current awareness of innovations, customer processing systems, and future expansion plans in diverse industries, in order to assist the commercial team in responding to increasing sales opportunities. The incumbent manages key Armor programs to successful completion as the direct technical interface between the commercial team and internal operations (Manufacturing, R&D, Customer Service) and acts as the primary interface/liaison between Engineering, Customer Service, R&D, Operations, and Commercial teams for Armor products. This role will require frequent visits to customers as well as hosting visits in support of the Armor commercial team. The most successful candidate will have a strong interest in customer relations and sales. IS THIS JOB FOR YOU? Education: Bachelor's Degree in Ceramic or Materials Engineering is required. Experience: 1+ years of experience in a manufacturing setting is required. 3+ years of experience in ceramic manufacturing is preferred. A TEAM READY TO WELCOME YOU Who are we? A strong international group company's Performance Ceramics & Refractories (PCR) leads the industry in the design, development and manufacturing of the highest performing solutions for extreme operating conditions. We strive to deliver value through our global technical expertise and the long-term partnerships we form with our customers. Our employees are committed to delivering the best solutions and services to meet the unique material and engineering needs of our customers. Ceramic & refractory solutions for broad industrial applications provide an end-to-end solution for your business. Our performance ceramic (advanced / fine ceramic) solutions cover industrial kiln & furnaces, specialty ceramics, burner solution for industrial heating, wear resistance applications (mining, bulk handling in iron & steel making), wine & beer filtration, industrial filtration, Armor, metrology, labware, and many more demanding applications which rely on high performance ceramic material characteristics. Our performance refractory solutions are designed and manufactured to overcome operational challenges in metallurgical applications. Refractory bricks, tiles, castable and mortars for every equipment are used for ironmaking, steelmaking, primary aluminium, copper, zinc galvanizing, foundry, carbon black, petrochemicals, and also Waste-to-Energy (WtE). At the company we design, manufacture and distribute materials which are key ingredients in the wellbeing of each of us and the future of all. Join our innovative, passionate and entrepreneurial community to improve the world of tomorrow with us. The candidate will, generally, perform the following duties: Identify customer needs and, in close cooperation commercial team, adapt existing products and services to meet those needs within the framework of our capabilities; understand the current applications and products and can serve as the expert and the reference in the application for our customers. Work with the process engineers across all plant departments, and the commercial team, in trouble shooting customer issues. Show continuous improvement in product or process development by improving manufacturing processes: developing ways to reduce scrap and rework, increase productivity/efficiency and decrease operating costs. Initiate and maintain Engineering Change Notices (ECN) to document and control changes in specifications, processes, and procedures. Act as a technical support to the manufacturing floor for the Armor product line and work to solve assigned engineering problems including checking the work of others within relevant departments. Manage assigned projects, engineering trials and prototype builds including project scheduling, performance, implementation, and writing reports in coordination with requested completion dates. Participate in all Armor customer calls and visits alongside commercial team, and attend trade shows and visit customers as required. What are our Perks? Excellent Healthcare: Medical, vision, prescription & dental Family Focus & Balance: Parental leave, paid time-off and Employee Assistance Program Financial Security: Competitive 401(k), Company-funded Retirement Accumulation Plan and Employee Stock Purchase Program (PEG) Tuition Reimbursement: Continuing education for every season of your career Pet Insurance options: Insurance plan & prescription discount program for your furry friends PerkSpot: Our exclusive one-stop online discount marketplace LiveWell: Rewarding you for living a healthy lifestyle MUST HAVE Bachelor's Degree in Ceramic or Materials Engineering is required. 1+ years of experience in a manufacturing setting is required. NICE TO HAVE 3+ years of experience in ceramic manufacturing is preferred. Package Details Excellent Healthcare: Medical, vision, prescription & dental Family Focus & Balance: Parental leave, paid time-off and Employee Assistance Program Financial Security: Competitive 401(k), Company-funded Retirement Accumulation Plan and Employee Stock Purchase Program (PEG) Tuition Reimbursement: Continuing education for every season of your career Pet Insurance options: Insurance plan & prescription discount program for your furry friends PerkSpot: Our exclusive one-stop online discount marketplace LiveWell: Rewarding you for living a healthy lifestyle
    $65k-81k yearly est. 60d+ ago
  • Production Process Engineer

    Cook Group 4.3company rating

    Poway, CA jobs

    Accountable for applying engineering techniques to the Production Operation in support of the company's strategic plan. Recommends manufacturing equipment and processes designed to be efficient, cost-effective, and to promote quality and reliability. Assesses current equipment and processes, and makes recommendations for changes. Helps to troubleshoot and repair equipment. Performs process engineering assignments (Equipment, Logistics, Operator Training, etc.) with detailed project plans and timelines. Work from generally stated objectives and guide the direction of assigned projects. Communicates detailed project status to all levels. Pay Range: $90,000 - 105,000/yr Responsibilities Evaluate existing Production processes, develop, recommend, document and implement new processes to improve quality, reduce costs and reduce cycle time. Assess machine capability and capacity Perform validation studies, with appropriate specified protocols Provide training to other personnel (production and engineering) as needed Perform customer Contract Review to ensure compliance to process capabilities Evaluate and Certify new Production equipment Investigate and solve technical problems as they occur Qualifications Education and Experience: Minimum 2 years exempt-level engineering work experience in a non-assembly, non-automated manufacturing environment with a focus on manufacturing process improvement and hands-on experience with troubleshooting manufacturing equipment and processes. B.S. in Mechanical Engineering. Mechanical Engineering strongly preferred other engineering disciplines considered. Work experience may substitute for educational requirement, per K-Tube equivalencies chart. Job Knowledge, Skills and Abilities: Solid understanding of the structure and properties of metals Analytical thinking and problem solving skills. Ability to apply fundamental Lean and Engineering concepts to real world activities and problems. Good understanding of measuring systems, essentials of non-destructive testing, and sampling plans. Prefer multi-disciplinary engineering experience, demonstrating the ability to apply engineering principles to explain observed system behavior. Prefer experience with database structures, ERP, 3D modeling, and/or programmable controllers. Must have good communication skills, both written and spoken. Must be proficient with MS Word, Excel, Power Point, Outlook and SolidWorks Physical Requirements: Must be able to lift up to 25 pounds Light to moderate physical effort required Regularly required to sit or stand, reach and move about the facility Work Environment: Work performed in both a manufacturing and office environment Exposure to metals, lubricants, solvents, electrolytes and other hazardous materials Personal Protective Equipment: Safety glasses and safety shoes are required Other personal safety equipment required as listed in SDS depending on task may include safety goggles, ear protection, full - face shield, apron, arm guards, rubber boots and gloves Position Type: Hybrid - typically requires 3 days per week in the office and additional days as necessary Status: Full Time/Exempt Reports to: Operations Manager We offer US based employees: Competitive base and bonus Medical, dental, and vision insurance 401(k) plan with ER match - 100% on first 4% contributed, profit sharing plan with 6 year vesting schedule 15 days of PTO 8 paid holidays Office closure between December 23 - January 1 5 paid sick days Paid parental leave Tuition Assistance Qualified candidates must be legally authorized to be employed in the United States. K-Tube does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.
    $90k-105k yearly Auto-Apply 60d+ ago
  • Process Engineer I/II

    Organogenesis, Inc. 4.8company rating

    Canton, MA jobs

    About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: The Process Engineer II role is part of the Process Engineering department, and will be responsible for developing, implementing and maintaining robust and efficient manufacturing processes for new and existing medical devices and pharmaceutical products. This role works closely with Manufacturing, Product Development, and Quality teams to ensure processes are validated and controlled according to ISO 13485, FDA and other regulatory requirements. The position will drive continuous improvement projects to enhance product quality, reduce costs and improve manufacturing efficiency. How You Will Achieve It: * Specify and procure new capital equipment, overseeing installation and qualification protocols * Design, develop and implement new manufacturing processes, equipment, tooling and fixtures for new product introductions * Conduct process simulations and analyze data to identify inefficiencies , reduce cycle times and minimize scrap * Assist in development and execution of process validation protocols to ensure processes consistently meet quality standards * Support internal and external audits by providing documentation and expertise on manufacturing processes * Conduct process risk assessments, such as PFMEA, to identify and mitigate potential risks to product quality and patient safety * Support the transfer of processes and products from development to commercial manufacturing, facilitating successful scale-up * Prepare engineering drawings, specifications, protocols and reports for internal use and regulatory submissions * Support all manufacturing systems, current and new. Job Requirements What You Need to Achieve It: * Bachelor's Degree in Chemical/Bio-Medical Engineering or equivalent with 2 to 5 years' experience * Ability to work on multiple projects simultaneously. * Experience working in a GMP environment/medical device industry and ensure 21 CFR Part 820, ISO 13485 and FDA biologics requirements are met. * Ability to read, write and comprehend English. * Good computing skills including Microsoft office. * Strong communication, interpersonal, and presentation skills for working with diverse teams and management. * Ability to solve practical problems both individually and in a team environment. * Work independently with minimal supervision. * Knowledge of GMP, GAMP guidelines, IEEE specifications, ISA specifications, ASTM specifications and batch process control in the life science industry. * Working knowledge of SolidWorks and AutoCAD Software is desirable. * Experience using AutoCAD and/or Solidworks * Experience in medical device design and application of test standards. * Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills beneficial. * Experience working in a hands-on environment. * Experience building and setting up equipment. * Understanding of PLC's would be helpful but not required. * Familiarity with manufacturing automation systems is helpful but not required. * Ability to read standard electrical diagrams and logic schematics. What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint The anticipated annualized base salary for a Level I role is $66,500 - $83,000 and for a Level II is $85,500 - $107,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Physical Required Job Type Full-time Location Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary) Education Bachelor's Degree Career Level Individual Contributor Travel
    $85.5k-107k yearly 60d+ ago
  • Future Opportunity - Process Engineer (Summer 2026 New Grad)

    Genesis 3.9company rating

    Houston, TX jobs

    About Technip Energies At Technip Energies, we are more than just a leading engineering and technology company; we are pioneers committed to shaping a sustainable future. With over 65 years of experience and 17,000+ talented professionals worldwide, we deliver innovative solutions to real-world energy challenges. We believe in the power of collaboration, diversity, and an inclusive culture where your well-being is a top priority. Join us on a one-of-a-kind journey where you can take pride in Being Part of the Solution for the benefit of our planet, people, and communities. If you share our vision of driving the transition to a low-carbon future and are eager to develop your skills for tomorrow, then this could be the perfect opportunity for you. We are currently seeking a Process Engineer I to join our Process & Technology team based in Houston, TX Please note this is a Pipeline requisition created for future hiring in Summer 2026. About the Job Delivery of technically & qualitatively high-level process engineering design within proposals, studies, projects execution & operations, as part of a study and/or project team, in accordance with design & engineering standards & procedures, schedules and budget, with a continuous concern for quality standards, targets and customer satisfaction. We offer you not only a job, but an inspiring journey in a truly global environment where you team up to break boundaries thanks to the innovation, creativity, resilience and team spirit expressed by our people. Responsibilities: Assists in the analyzing of project specifications, tender and proposals requirements. Contributes to the development of design parameters and methodologies. Participates in the preparation of technically correct, safe, environmentally friendly, cost & time effective discipline engineering analysis and solutions for approval. Provides support to all project activities, from engineering to start-up, as required. Interfaces with other process engineering disciplines and design team(s). Assists in development of a process knowledge databases for studies, projects and/or operations (capturing and reporting events & experiences within studies, projects & operations and writing of technical notes). May participate in pre-commissioning, commissioning, and start-up. Reports own activities within studies, projects and/or operations management. Participate in our Global Graduate Program: This graduate program gives you unique access to a diverse range of technologies and initiatives, offers you global exposure, a chance to connect with Technip Energies' leaders, and allows you to create a network of peers who are passionate about what they do: engineering a sustainable future. Through a tailored development and learning journey: we provide the tools and resources, and opportunities you need to thrive and have a direct impact. At Technip Energies we need to you to be part of the solution. About You We'd love to hear from you if your profile meets the following essential requirements: Qualifications: Minimum of a Bachelor's degree in Chemical Engineering First experience in process design / domain of specialty Theorical knowledge of process design/domain of specialty methods and tools Fluency in professional English Level of experience: Basic knowledge of theories, practices and procedures Less than 2 years of experience within process design / domain of specialty (please note internships and co-ops are not counted towards experience) Organizes own work to meet deadlines set by others. Applicants must be authorized to work for any employer in the United States. Employment is contingent upon proof of eligibility to work in the United States. #LI-RH1
    $59k-79k yearly est. Auto-Apply 60d+ ago
  • Process Engineer - Contract

    Genesis 3.9company rating

    Houston, TX jobs

    Technip Energies is a global technology and engineering powerhouse. With leadership positions in LNG, hydrogen, ethylene, sustainable chemistry, and CO2 management, we are contributing to the development of critical markets such as energy, energy derivatives, decarbonization, and circularity. Our complementary business segments, Technology, Products and Services (TPS) and Project Delivery, turn innovation into scalable and industrial reality. Through collaboration and excellence in execution, our 17,000+ employees across 34 countries are fully committed to bridging prosperity with sustainability for a world designed to last. T.EN Workforce Solutions (TWS) is a proud member of the Technip Energies (T.EN) family, a premier supplier of proven management, technical and skilled talent recognized for delivering valuable and sustainable personnel solutions to our clients in the energy, infrastructure, commercial, and resources industries. On behalf of our client, we are currently seeking a Process Engineer on a contract basis (with potential to go full time). T.EN Workforce Solutions (TWS) is a wholly owned subsidiary of Technip Energies USA. Established in 2024 to serve as the in-house agency supporting the T.EN X business line with highly skilled PMC personnel, and where appropriate, also serve the remaining Technip Energies business lines within the broader U.S. market. Our focus includes fixed-term project staff, temporary supplemental personnel, W2 consultants, and subject matter experts on an ad-hoc basis. About us: Technip Energies is a global technology and engineering powerhouse. With leadership positions in LNG, hydrogen, ethylene, sustainable chemistry, and CO2 management, we are contributing to the development of critical markets such as energy, energy derivatives, decarbonization, and circularity. Our complementary business segments, Technology, Products and Services (TPS) and Project Delivery, turn innovation into scalable and industrial reality. Through collaboration and excellence in execution, our 17,000+ employees across 34 countries are fully committed to bridging prosperity with sustainability for a world designed to last. About the opportunity we offer: Purpose: The Principal Process Engineer will develop process models and sizing of major equipment to assist in conceptual studies, feasibility studies, Pre-FEED, FEED and Brownfield studies. Provides support to Development Planning studies across a range of Downstream and Energy Transition in Refining, Petrochemical and oil and gas projects. Supports other engineering projects as needed based on her/his specific competencies and skills. Liaise with subject matter experts across a wide range of disciplines. Role Responsibility: Executing study activities under the supervision of the Study Manager Assist with the preparation of process discipline manhour estimates for proposals. Developing process simulation models for Downstream Refining, Petrochemicals, oil and gas processing and export, PFDs, H&MBs and P&IDs development. Sizing of Unit Operations using inhouse tools, ASPEN Hysys, ProMax, or other software Preparing study deliverables such as process design basis, technical reports, process schematics, descriptions, and presenting simulation results in a simplified manner Requirements: Holds an engineering degree in Chemical Engineering. Minimum 5-10 years of process engineering experience within the downstream refining, petrochemicals, sustainable energies industry working in a capital project and/or in operations environment. Strong technical knowledge of downstream refining, petrochemicals, sustainable energies production/processing systems. Experience working with or supporting equipment material requisitions such as pumps, compressors as well as auxiliaries such as turbines will be a plus. Performed both steady state and transient process simulations. Debottlenecking experience of existing facilities would be a plus. Basic knowledge of LNG processes, Hydrogen, CCUS and energy transition experience would be a plus. Experience in identification, evaluation, and recommendation of concept options, e.g. process design, brownfield modifications would be a plus. Basic understanding of project economics and cost estimating Understanding of conceptual engineering, strong process modelling experience would be a plus. Previous experience with AACE class 4/5 estimating tools will be a plus. Competency with Excel and Excel-based tools Familiarity with business intelligence tools, PowerBI, SQL DB, AI/ML algorithms is a plus Strong technical writing skills Effective time-management skills Strong problem-solving skills Strong written and oral communication skills are essential. About you: We love to hear from you and how you match with this position. Your career with us: Working at Technip Energies is an inspiring journey, filled with groundbreaking projects and dynamic collaborations. Surrounded by diverse and talented individuals, you will feel welcomed, respected, and engaged. Enjoy a safe, caring environment where you can spark new ideas, reimagine the future, and lead change. As your career grows, you will benefit from learning opportunities at T.EN University, such as The Future Ready Program, and from the support of your manager through check-in moments like the Mid-Year Development Review, fostering continuous growth and development What's next? Once receiving your application, our Talent Acquisition professionals will screen and match your profile against the role requirements. We ask for your patience as the team completes the volume of applications with reasonable timeframe. Check your application progress periodically via personal account from created candidate profile during your application. We invite you to get to know more about our company by visiting and follow us on LinkedIn, Instagram, Facebook, X and YouTube for company updates. #LI-AH1
    $59k-79k yearly est. Auto-Apply 60d+ ago
  • Process Engineer

    Greenlight Biosciences 4.1company rating

    Rochester, NY jobs

    ABOUT GREENLIGHT GreenLight Biosciences is using RNA to create a world where plants, people, and the planet can thrive together. The company is developing highly effective agricultural solutions for farmers and beekeepers that are targeted to specific pests and degrade quickly in the environment. Our pipeline includes products to protect honeybees and a range of fruits and vegetables. The GreenLight platform allows us to research, design, and manufacture across multiple product categories including insecticides, fungicides, and herbicides. For more information, visit ********************** GreenLight Biosciences is looking for a Process Engineer to be responsible for process design and process/operations improvement for our RNA technology production in Rochester, NY. The successful candidate will be able to improve our industrial processes to enhance efficiency, reliability and ensure safe operations while reducing costs. ESSENTIAL DUTIES AND RESPONSIBILITIES (including the following, however, other duties may apply.) • Develop, configure, and optimize the GreenLight Bio's industrial processes from inception through to start up and certification. • Design, run, test and upgrade systems and processes. • Develop best practices, routines, and innovative solutions to improve production rates and quality of output. • Perform process simulations. • Assess processes, take measurements, and interpret data. • Troubleshooting is a key skill. • Manage cost and time constraints. • Perform risk assessments. • Provide process documentation and operating instructions. • Comply with OSHA, EPA and GreenLiht Bio's safety and environmental policies. SUPERVISORY RESPONSIBILITIES Indirect leadership responsibilities. QUALIFICATIONS • Proven work experience in process engineering. • Excellent technical skills. • Knowledge of process related standards. • Experience in process simulations. • Working knowledge of process engineering software packages. • CAD or AutoCad skills. • Instrumentation and automation knowledge a plus. EDUCATION and/or EXPERIENCE • BS degree in Chemical Engineering or similar • At least 5 years of experience in the Biosciences Process Manufacturing Industry (Chemical, Petrochemical, Refinery, etc.) or equivalent technical role • Experience working in a startup facility such as in food or enzyme processing, or chemical industries • Strong analytical skills • Excellent oral and written communication skills. • Knowledge of OSHA and EPA state/federal rules and regulations preferred. • Knowledge of computerized work order systems is preferred. PERSONAL ATTRIBUTES · Strong time management skills · Ability to maintain focus when working individually. · Team player: within department and with other departments · Eye for details · Effectively communicate and understand job instructions both verbally and written · Ability to perform basic mass and energy balance computations. Ability to apply engineering concepts to practical situations. · Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. · Familiarity with environmental, health and safety regulations. · Analytical thinker with interpersonal skills. WORK ENVIRONMENT While performing the duties of this job, the employee will be working in an industrial environment. The ability to wear a respirator and hearing protection is a requirement. Proper Personal Protective Equipment (PPE) will be provided and must be worn. Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $67k-88k yearly est. Auto-Apply 60d+ ago
  • Sterilization Process Engineer

    Applied Medical Distribution Corporation 4.4company rating

    Irvine, CA jobs

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description The Sterilization Process Engineer at Applied Medical plays a vital role in ensuring the safety, quality, and compliance of medical devices through the development, validation, and optimization of sterilization processes. This position contributes to Applied Medical's mission of advancing healthcare by designing and maintaining sterilization systems that meet stringent industry standards. The Sterilization Process Engineer collaborates closely with cross-functional teams to support product innovation, manufacturing efficiency, and regulatory compliance across Applied Medical's product portfolio. Key Responsibilities * Develop and validate sterilization processes for new and existing medical devices, ensuring compliance with regulatory and industry standards. * Qualify, maintain, and troubleshoot electron beam sterilization systems and associated equipment to ensure optimal performance and reliability. * Qualify, maintain, and troubleshoot ethylene oxide sterilization systems and equipment to support consistent and effective sterilization cycles. * Conduct root cause analyses and develop corrective and preventive actions (CAPA) to address non-conformances and improve process control. * Generate and update engineering documentation, including drawings, quality instructions, test protocols, and validation reports. * Collaborate with production, quality assurance, and R&D teams to support continuous improvement in manufacturing and sterilization operations. * Participate in cross-functional problem-solving initiatives to improve product quality, system reliability, and regulatory compliance. * Maintain current knowledge of sterilization validation procedures, process standards, and applicable ISO and FDA guidelines. Success in This Role Looks Like * Delivering validated, reliable sterilization processes that ensure product safety and meet global regulatory requirements. * Collaborating effectively with cross-functional engineering and manufacturing teams to support high-quality medical device production. * Proactively identifying process improvements that enhance efficiency, reduce downtime, and improve compliance outcomes. * Demonstrating technical expertise and problem-solving skills in troubleshooting sterilization systems and optimizing performance. * Maintaining accurate and compliant engineering documentation that supports audits, validations, and continuous improvement efforts. Position Requirements This position requires the following skills and attributes: * Bachelor's degree in engineering or a scientific discipline relevant to sterilization processes or equipment (e.g., mechanical engineering, chemical engineering, or microbiology). * Ability to analyze, understand, and troubleshoot complex systems, including sterilization equipment and process controls. * Strong oral and written communication skills for documentation, technical reporting, and team collaboration. * Proven ability to develop innovative and practical solutions to complex engineering challenges. * Demonstrated ability to work independently and manage multiple projects, priorities, and deadlines. * Strong interpersonal and teamwork skills, with the ability to collaborate across engineering, production, and quality teams. Preferred The following skills and attributes are preferred: * Familiarity with electron beam (e-beam) sterilization systems or comparable radiation-based technologies. * Familiarity with ethylene oxide (EtO) sterilization systems and related validation methods. * Experience programming, operating, or troubleshooting Programmable Logic Controllers (PLCs). * Experience working in a laboratory setting * Knowledge of sterilization validation standards and procedures for radiation and ethylene oxide sterilization (e.g., ISO 11135, ISO 11137). * Understanding of medical device manufacturing and quality system requirements. Benefits * Competitive compensation range: $71000 - $75000 / year (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.
    $71k-75k yearly Auto-Apply 50d ago
  • Process Engineer

    CSI 4.3company rating

    Springfield, MO jobs

    CSI is looking for a Process Engineer that is detail oriented and able to solve problems accurately with an "outside the box" approach. This position requires the ability to learn quickly in a fast paced environment. Technical support for diagnosing, troubleshooting, and repairing equipment to field technicians, customers, and internal staff will be required. Key responsibilities of this role include meeting with customers, designing and bidding of potential projects, assistance and support of shop crews, and calculations of fluid dynamics, heat transfer, blending, mixing, etc. The Process Engineer must be able to manage multiple projects simultaneously, both in and out-of-house. Excellent interpersonal, written, and verbal communication skills are required to build successful relationships with co-workers, vendors, and external customers. About CSI: CSI provides state-of-the-art stainless steel process equipment and service to the food, dairy, beverage, pharmaceutical, and personal care industries. We are a growing company with a passion for providing superior customer service. Our work environment is rooted in respect, teamwork, continual learning, growth and community. We believe our employees are our greatest resource which is why we are committed to investing in our team. We offer a wide range of benefits including health and wellness, paid time off, retirement planning and continuing education support. We also enjoy hosting company luncheons, casual Fridays, a wellness program and providing opportunities for volunteering in local community charitable events! We re looking for fun and energetic candidates that want to join our growing family and ensure our customers delight in CSI. If this sounds like you, what are you waiting for? Apply now! Compensation: Salary commensurate with skills and experience Education/Training: Bachelor s degree in engineering; mechanical or chemical preferred Valid driver s license Required Experience: 3 years in managing or designing hygienic process systems projects Project management experience Piping design, pipe fitting or welding Industrial food system processing and Bio Pharmaceutical environments System design, equipment, and instrumentation selection CAD design Computer proficiency PLC Control Systems Experience a plus Persons in this position may be exposed to temperature extremes both hot and cold, dust, and noise. This position may also require lifting of heavy objects during truck loading and unloading or equipment placement. Must wear respirators, safety harnesses and other safety devices as required by the customer. More than 40 hours per week will normally be required in order to achieve the productivity necessary for this position. Overnight travel, Saturday, Sunday, and holiday hours may be required. CSI has a long standing policy of Equal Opportunity in employment. Our practice is to fill positions by selecting applicants who can perform the work in a competent and professional manner. We do not discriminate on the basis of age, sex, race, color, religion, national origin, sexual orientation, gender identity, protected veteran status, or individuals with disability. U.S. federal law requires completion of employment eligibility verification upon hire. CSI participates in E-Verify. Must have the right to work in the United States.
    $63k-77k yearly est. 60d+ ago
  • Process Engineer

    Byheart 3.2company rating

    Pennsylvania jobs

    ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That's why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby-no matter how they do it. When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we've been leading the way in a lot of ways. We're… The only U.S.-made infant formula to use organic, grass-fed whole milk The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list The first infant formula company to receive Clean Label Project's Purity Award (and we test for 700 contaminants vs the required 400) We ran the largest clinical trial by a new infant formula brand in 25 years-clinically proving our benefits vs a leading infant formula like: Less spit up Softer poops Easier digestion More efficient weight gain Enhanced nutrient absorption Longer stretches between nighttime feeds* ByHeart has rapidly emerged as a leader in infant nutrition, fortifying the domestic supply chain by owning end-to-end manufacturing in 3 US facilities and ranking in the top 10% of the U.S. infant formula category within just one year. Strategic partnerships with retailers like Walmart and Whole Foods have expanded access to their premium, science-backed formula, now available in over 70% of U.S. stores. With >$400M in funding, we're shifting the industry forward-and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >300 people that stretches across the country. We're proud to offer competitive, family-first benefits, including but not limited to: Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family. Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion! 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time. Up to 6% 401(k) Match to help you plan for your future. Company equity for every employee: because when we succeed, we succeed together! Visit our site to learn more, and check out some recent press on ByHeart: Entrepreneur: The Illusion of the Shelf - The Driving Force Behind Infant Formula Shortages, and What Needs to Change Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years. Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula Axios: Infant formula maker ByHeart raises $95 million BabyCenter: 2024 Best formula for Breastfed Babies New Modern Mom: The Clean Formula Moms Are Loving *based on data from infants at approximately 4 months of age The responsibilities of the Process Engineer are to develop, monitor, and elevate the performance of the company's vital business systems and processes by detecting potential problems and taking the unwanted deviation, defects, and delay out of the production process. Essential Duties & Responsibilities • Support production in identifying, verifying, analyzing, and implementing process improvement and process re-engineering opportunities. • Provide technical and analytical support for process improvement initiatives. • Develop process analysis and re-engineering to improve efficiency, lower costs, and improve product quality. • Perform project management, analytics, and measure to ensure milestones are met and deliverables achieved. • Identify and manage resources to deliver effective solutions. • Establish norms and standards of production. Competency & Skill Requirements • Ability to communicate effectively with all levels of the organization • Ability to plan and manage priorities • Demonstrated problem-soling and analytical skills • Ability to lead cross-functional teams across all levels of the organization Education and/or Experience Requirements • Bachelor's degree in a related field or a minimum 5-7 years proven continuous improvement analytical experience from a similar role, including project management and business analysis. • Infant Formula manufacturing a plus. Education & Experience Requirements • Bachelor's degree in a related field or a minimum 5-7 years proven continuous improvement analytical experience from a similar role, including project management and business analysis. • Dry spraying experience required, preferably in food processing or dairy industries. Infant Formula manufacturing a plus. Physical Requirements • Need ability to stand, crouch and climb to perform adjustments to equipment, use ladders, and perform various types of manual labor. Regulatory Requirements • Adhere to all safety policies and procedures, follow CGMP's, and work in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements. • Will comply with all applicable federal, state, and local standards for the manufacture of infant formula and other non-infant nutritional foods. We're excited about your interest in joining ByHeart! Our Talent Acquisition team reviews applications in the order they are received and will reach out directly to schedule interviews. We kindly ask that you refrain from contacting hiring managers or current employees directly. We are 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, or any other characteristic protected by law.
    $64k-84k yearly est. Auto-Apply 60d+ ago
  • Process Engineer

    Applied Medical Distribution Corporation 4.4company rating

    Rancho Santa Margarita, CA jobs

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role. Areas of Responsibility As a Process Engineer, you will work within the Group Process Development team and use skills related to sustaining and improving production manufacturing processes as part of a cross-functional team. The Process Engineer's primary responsibilities are debugging, observing, and expediting shop orders. You will assist with developing and updating engineering documents and investigating new tooling, materials, manufacturing processes, and technologies. * Collaboration: Work closely with cross-functional teams, including operators, a variety of engineers, and quality assurance, to achieve overall business objectives. * Project Management: Manage projects related to process improvement, including timelines, budgets, and resources and coordinate effectively with different departments to ensure project success. * Problem Solving: You will be responsible for identifying and resolving issues that arise. This will include taking action to solve the problem by generating ideas for the solution, finding out the reasons behind the problem, and implementing the solution. * Communication: Strong communication skills are essential for effectively conveying ideas, collaborating on projects, and presenting findings or recommendations. Position Requirements * 1-10 years of relevant Engineering work experience * Bachelor's degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering (or equivalent) * Experience with manufacturing equipment and processes * Experience with computer-aided design (i.e. SolidWorks), spreadsheets, scheduling programs, and word processing * Excellent technical writing * Experience with Statistical Process Control (SPC) * Working knowledge of Geometric Dimensioning and Tolerancing (GD&T) * Working knowledge of a variety of materials and mechanical designs * Ability to work effectively in cross-functional teams * Effective oral and written communication skills * Technical aptitude and detail oriented Preferred * Experience in the medical device industry * Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems * Experience with software such as NetWeaver/Product Lifecycle Management * Experience with Minitab or other statistical analysis software * Leadership or project management experience * Excellent organization, communication, and documentation skills Inside this Business Group The Group Process Development team is responsible for support of the manufacturing processes for their respective product families. They help with concept development, product testing, prototyping, feasibility testing, and design for manufacturing. They ensure that the manufacturing components and procedures are designed and validated to meet the company's performance, value, quality, and cost requirements. This involves collaborating with other teams including, but not limited to, Quality Systems, Regulatory Affairs, and Clinical Development. Benefits * Competitive compensation range: $70000 - $95000 / year (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.
    $70k-95k yearly Auto-Apply 60d+ ago
  • Process Engineer

    Hyde Engineering Consultants 4.1company rating

    Raleigh, NC jobs

    The Process Engineer provides site-based support to pharmaceutical and biopharmaceutical clients in the RTP Area. This role supports the conceptual design, basis of design, and detailed design of a production facility, providing support for FAT's off-site activities, SAT's, commissioning, automation, and/or Project Management. Responsibilities * Support / lead the design and specification of cGMP equipment, processes and utilities. * Create and review project documentation * Concept Design (Redlines for Circuits and Flowpaths) * Engineering CIP Skid Capacity Assessment, Preliminary Hydraulics, New Equipment Sizing, New Line Sizing, New Valve, Instrument List.,) * Liaise with client end user groups to ensure correct specification of equipment and utilities. * Create Technical & Functional Specification for automated and manual equipment. Required Skills and Experience * BS degree or higher in chemical or mechanical engineering * 10+ experience in the Biopharmaceutical industry * Engineering Drawings * Process Flow Diagrams (PFD) * Piping & Instrumentation Diagrams (P&ID) * General Arrangements (GA) * Floor Plans * Piping Plans * Vendor Mechanical Shop Drawings Equipment Data Sheets, Valve & Instrument Lists Engineering Calculations Equipment Sizing - tanks, pumps, filters, etc. Piping and valve sizing for pressure drop Utility consumptions Specifications User Requirement Specs (URS) Functional Requirement Specs (FRS) Software Design Specs (SDS) Factory and Site Acceptance Testing ( FAT / SAT) Ability to read automation documentation and translating process information to automation berbiage Clean Utilities and/or Stainless Steel Process Equipment Design. Large Powder Charging and Mixing Operations for Buffers (large SS tanks, mixers, material lifts, etc.) Familiar with ASME BPE standards Startup/Commissioning Activities Spray Coverage Testing Cleaning Cycle Development/Optimization/Troubleshooting Are you looking for a meaningful career that makes a difference in the world? Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website: *************** Hyde Engineering + Consulting is an equal opportunity, affirmative action employer. #LI-JS1 #LI-Hybrid Associate
    $62k-78k yearly est. 33d ago
  • Process Engineer I

    Applied Medical Distribution Corporation 4.4company rating

    Rancho Santa Margarita, CA jobs

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description The Labeling Process Engineer I at Applied Medical is responsible for designing, developing, and implementing labeling processes for a wide range of medical device products. This role ensures compliance with regulatory requirements and supports quality control throughout the labeling lifecycle. Working onsite at our global headquarters, the Labeling Process Engineer I collaborates with cross-functional teams to optimize labeling workflows, reduce costs, and enhance manufacturing efficiency. Key Responsibilities * Design and implement labeling processes that meet regulatory standards and internal quality requirements. * Develop cost-effective solutions to optimize labeling workflows and improve overall manufacturing efficiency. * Maintain detailed documentation of labeling processes, procedures, and changes for compliance and audit readiness. * Collaborate with cross-functional teams, including operators, engineers, and quality assurance, to achieve business objectives. * Manage labeling-related projects, including timelines, budgets, and resources, ensuring successful execution. * Identify and resolve process issues through root cause analysis and implementation of effective solutions. * Support continuous improvement initiatives by researching new technologies and best practices for labeling systems. Success in This Role Looks Like * Deliver compliant, efficient labeling processes that meet regulatory and business requirements. * Achieve measurable improvements in labeling accuracy and production efficiency through process optimization. * Lead cross-functional initiatives that enhance collaboration and streamline labeling workflows. * Ensure timely completion of labeling projects within budget and ahead of schedule. * Contribute to Applied Medical's mission by supporting high-quality, cost-effective medical device manufacturing. Position Requirements This position requires the following skills and attributes * Hold a Bachelor's degree in engineering * Demonstrate experience in SolidWorks 3D modeling and familiarity with mechanical, pneumatic, and electrical devices. * Possess strong technical writing skills and ability to maintain detailed documentation. * Exhibit effective verbal, written, and interpersonal communication skills for collaboration across teams. * Work independently in a fast-paced environment, managing multiple tasks and priorities. * Display self-motivation, problem-solving ability, and adaptability to changing project requirements. Preferred The following skills and attributes are preferred * Knowledge of manufacturing processes and experience in packaging, medical, or pharmaceutical industries. * Experience with product labeling or labeling materials. * Ability to create detailed engineering drawings for fabrication and assembly. * Hands-on experience building automated equipment, electro-mechanical systems, or mechanical prototype fixtures. * Experience specifying or designing automated equipment for labeling or packaging. * Proficiency in testing and analysis, including designing test plans and conducting failure analysis. * Project management experience, including developing project plans, timelines, and tracking deliverable progress. Benefits * Competitive compensation range: $71000 - $80000 / year (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.
    $71k-80k yearly Auto-Apply 24d ago

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