Senior Process Engineer

Senior Process Engineer

Join a leading medical technology organization where you'll play a key role in bringing innovative products from development to manufacturing. This hybrid contract opportunity offers hands-on involvement with new product introductions, process validation, equipment implementation, and continuous improvement initiatives within a highly regulated environment. Ideal for engineers who enjoy collaborating across teams, driving process excellence, and making a direct impact on product quality and patient outcomes.

Responsibilities

• Provide engineering support for new product and process introductions, ensuring activities are completed and documented in accordance with Stryker new product development procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements.
• Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
• Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals.
• Analyze equipment to establish operating data and conduct experimental test and result analysis.
• Use engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
• Participate in process review meetings.
• Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP), and production part approval process (PPAP) generation associated with product transfers and launches.
• Complete capability studies for in-process inspection and generate subsequent inspection documentation.
• Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes; review and approve validation documentation.
• Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development.
• Drive and execute effective communication with all stakeholders to enable project success.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.

Requirements

• 2+ years of relevant work experience – required
• Bachelor's degree in engineering – required
• Bachelor's degree in Industrial or Systems Engineering – highly preferred
• Lean Six Sigma Green Belt Certification or above – preferred
• Knowledge of manufacturing processes, materials, product, and process design – preferred
• Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques – preferred
• Experience writing and executing validations – preferred
• Experience in new product introduction or manufacturing engineering – preferred
• Experience in an FDA regulated or regulated industry – preferred

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific