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Process Engineer – Product Development and SustainmentÂ
Department: Engineering
Reports To: Senior Engineering Manager
We are looking for a Process Engineer – Product Development to join our Engineering team and support the development and commercialization of innovative medical devices. In this role, you will contribute to the design, development, validation, and optimization of manufacturing processes that ensure reliable, scalable, and compliant production.
You will collaborate closely with Design Engineering, Quality, Operations, and external partners to translate product designs into robust manufacturing processes aligned with ISO 13485 and FDA regulatory requirements.
This is an excellent opportunity for an engineer who enjoys hands-on problem solving, process development, and cross-functional collaboration in a regulated manufacturing environment.
Key Responsibilities
Support process development for new products, including concept trials, prototyping, DOE, and scale-up activities
Develop and optimize manufacturing processes for molding, assembly, bonding, and packaging
Participate in Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews with design teams and customers
Execute process validation activities (IQ/OQ/PQ) including protocol development, execution, and reporting
Support tooling qualification activities such as T0/T1 trials and FAT/SAT
Analyze process capability (Cp/Cpk), yield, and scrap data to improve performance
Assist with root-cause investigations during pilot builds and early production
Develop and maintain PFMEA, Control Plans, and process documentation
Collaborate with automation partners, suppliers, and cross-functional teams
Contribute to continuous improvement initiatives to enhance manufacturing robustness and efficiency
Qualifications
Bachelor’s degree in Mechanical, Industrial, or related Engineering discipline
1–5 years of process engineering experience (medical device industry preferred)
Experience with manufacturing process development and validation (IQ/OQ/PQ)
Knowledge of DOE, SPC, and statistical tools (Minitab or JMP preferred)
Familiarity with ISO 13485, ISO 9001, and ISO 14971 risk management principles
Experience developing PFMEA and process documentation
Strong analytical, problem-solving, and communication skills
Why Join Us
Work on innovative medical technologies
Collaborate with cross-functional engineering teams
Gain experience in product development and manufacturing scale-up
Be part of a quality-driven and innovation-focused environment
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