Job Description
Process Engineer -
Medical Device Manufacturing Pay:
$45.17/hr. - $49.59/hr. Duration:
1 year, Contract, W-2 Onsite in Waltham, MA Our medical device client is seeking a Process Engineer to support a precommercial medical device manufacturing environment as the organization prepares for FDA clearance and ramps up production . This role will focus on evaluating, refining, and validating manufacturing processes to ensure they are scalable, compliant, and capable of consistently producing high-quality products. The ideal candidate brings hands-on experience in regulated medical device manufacturing and can quickly assess current-state processes , identify improvement opportunities , and help build a robust production foundation. Key Responsibilities & Qualifications:
Support a precommercial medical device program pending FDA clearance by establishing and strengthening manufacturing processes in preparation for production scale-up. Evaluate existing manufacturing processes , identify gaps, and implement improvements to support efficient, repeatable, and compliant production as the team ramps output. Lead or support process development, transfer, optimization, and validation activities , including IQ/OQ/PQ
, process characterization, and continued process monitoring. Use statistical methods and data-driven problem solving to improve process capability and product quality, including DOE, root cause analysis, and corrective and preventive actions. Develop and review technical documentation such as protocols, reports, process specifications, work instructions, and validation records. Partner cross-functionally with manufacturing, quality, and operations teams to ensure readiness for production ramp and alignment with quality system and regulatory requirements. Demonstrate working knowledge of risk management and design control practices , including FMEA, control plans, and design transfer activities. Bring experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming, bonding, precision assembly, and/or injection molding. Troubleshoot complex manufacturing issues, interpret engineering drawings and GD&T, and support implementation of practical, scalable process solutions. Proficiency with Minitab or similar statistical tools is preferred, along with strong project management and technical communication skills. A Six Sigma Green Belt or Black Belt is a plus, as is familiarity with electro-mechanical or capital equipment manufacturing processes. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.
