Process Engineer

Full-time

Location: Kalamazoo, Michigan

Engineering @ Sterling Industries

They say good engineers love solving puzzles. Every day, our team figures out how to build and improve our clients’ innovative MedTech solutions, manufacturing them at scale, ready to improve patients’ lives. It is a mission that requires multi-disciplined, creative, and flexible minds, working together for our clients’ success. Whether it is process, mechanical or quality control engineering, every member plays an important role, making our team stronger. If you want to put your engineering skills to work on delivering the next generation of medical devices to patients around the world, Sterling is the place for you.

About Sterling Industries

Established in 1984, Sterling Industries provides end-to-end contract manufacturing and assembly of medical devices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs and fast-growing “scale-ups.” Registered with the U.S. FDA and Health Canada, Sterling helps clients deliver successful products through its vertical integration, managing the entire process, including the supply chain, manufacturing, assembly, testing, labelling, packaging and shipping. The company operates from facilities in the suburban Toronto (Concord and Woodbridge) and Kalamazoo, Michigan. Sterling manufactures success.

Overview

The Process Engineer (Product Development) will design, develop, verify, and validate manufacturing processes for medical devices, ensuring processes are robust, efficient, and compliant with regulatory standards such as ISO 13485, FDA 21 CFR 820, and applicable customer requirements. In this role, the engineer will support product development by driving Design for Manufacturing (DFM) and Design for Assembly (DFA), leading process characterization and validation activities (IQ/OQ/PQ), and collaborating with cross-functional teams to support tooling, automation, and successful design transfer to manufacturing. The position also involves monitoring process performance, supporting engineering changes (ECOs) and CAPA activities, and implementing continuous improvement initiatives to maintain quality, regulatory compliance, and operational efficiency throughout the product lifecycle.

Responsibilities

• Product Development
  • Collaborate with Design Engineering to define process requirements and ensure manufacturability (DFM/DFA).
  • Develop process flow diagrams, PFMEAs, control plans, and routings.
  • Develop and execute validation protocols (IQ/OQ/PQ) for new products and equipment.
  • Execute process characterization, DOE, and capability studies to establish process parameters.
  • Support tooling, fixture, and automation design.
  • Lead design transfer to manufacturing, ensuring readiness for pilot and full-scale production.
• Sustainment
  • Monitor and analyze process performance metrics (yield, scrap, downtime, and efficiency).
  • Own and manage Engineering Change Orders (ECOs) related to manufacturing documentation or tooling.
  • Lead and support nonconformance (NC) investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) in collaboration with Quality and Operations.
  • Identify and execute process optimization and cost reduction opportunities using Lean/Six Sigma.
  • Ensure validated processes remain compliant and well-documented within the QMS.

Requirements

• Bachelor’s degree in Mechanical, Industrial, or related Engineering discipline.
• 1-5 years of process engineering (medical device preferred).
• Experience in molding (preferred), assembly, and process development.
• Proven experience with validation (IQ/OQ/PQ) and URS/DS/FS packages.
• Skilled in DOE, SPC, and statistical tools (Minitab, JMP)
• Excellent communication skills, able to influence cross-functional discussions with QA/RA, Operations, PMO, Tooling, and suppliers.
• Working knowledge of ISO 13485, ISO 9001, ISO 14971, FDA 21 CFR 820, and design transfer requirements.
• Ability to write technical design documents and experience preparing design validation protocols and reports.
• Experience developing PFMEAs and supporting risk management documentation.

J. Sterling Industries will consider and provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform Sterling of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation. All information collected will be protected under applicable privacy requirements.

We will review applications as they are received. Only qualified applicants will be contacted.