POSITION OBJECTIVE: The Process Engineer (Product Development) designs, develops, verifies, and validates manufacturing processes for medical devices. This role ensures compliant and robust process development aligned with ISO 13485, FDA 21CFR 820, and applicable regulatory and customer requirements. This role drives DFM/DFA, process characterization and IQ/OQ/PQ validation, supports tooling and automation, and leads effective design transfer to manufacturing. The Process Engineer also monitors process performance, manages ECOs and CAPAs, and implements continuous improvements and regulatory compliance throughout the product lifecycle.

MAJOR DUTIES:

• 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.

• 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.

FUNCTIONAL COMPETENCIES:

• Results-Oriented – Delivers predictable, high-impact results across multiple workstreams and influences planning to prevent delays, improve production, and mitigate quality issues.
• Analytical Expertise – Skilled in evaluating data to identify relevant patterns, trends, and insights that support informed decision-making.
• Effective Problem Solver – Proficient in identifying issues, developing and evaluating alternative solutions, and executing effective action plans.
• Critical Thinker – Applies objective analysis to interpret data, minimizing bias and ensuring sound, evidence-based conclusions.
• Team-Oriented Collaborator – Demonstrates strong interpersonal skills and a commitment to shared goals through effective cross-functional collaboration.

POSITION 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.