Process Engineer

Job Summary: A Process Engineer in the medical device sector designs, implements, and improves manufacturing processes to ensure product quality, regulatory compliance, and operational efficiency. They collaborate with cross ‑ functional teams—including design, quality, and regulatory—to validate processes, troubleshoot issues, and support continuous improvement.

Essential Functions:

• Designs, develops, and optimizes manufacturing processes for new and existing medical devices.
• Conducts experiments and analyzes data to improve efficiency, reduce cost, and enhance product quality, consistent with process engineer roles that involve analyzing and upgrading processes
• Develops equipment layouts and process flow diagrams.
• Implements lean manufacturing and continuous improvement initiatives.
• Leads IQ/OQ/PQ validation activities to ensure processes meet FDA and ISO 13485 requirements.
• Ensures processes comply with safety, environmental, and regulatory standards, reflecting the need to meet compliance regulations in process engineering
• Prepares and maintains validation protocols, reports, and risk assessments.
• Monitors production processes and resolves technical issues to maintain consistent output quality.
• Supports root ‑ cause investigations and corrective/preventive actions (CAPA).
• Collaborates with quality engineers to ensure product consistency and adherence to acceptance criteria.
• Works with R&D to transfer new products into manufacturing.
• Partners with quality, regulatory, and supply chain teams to ensure smooth production and audit readiness.
• Supports documentation updates, including work instructions, SOPs, and process specifications.
• Analyzes process performance metrics and identify improvement opportunities.
• Prepares technical reports and present findings to engineering and leadership teams.

Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering field.
• Experience in a regulated manufacturing environment (medical device preferred).
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Strong analytical, problem ‑ solving, and statistical skills.
• Proficiency with CAD, statistical software, and process ‑ mapping tools.
• Ability to conduct risk assessments and validation activities.

Preferred but not required

Qualifications:

• Experience with automation, robotics, or advanced manufacturing technologies.
• Six Sigma Green Belt or Black Belt certification.
• Experience with cleanroom manufacturing or sterile device processes.
• Familiarity with Design for Manufacturability (DFM) and Design Transfer.
• Strong problem‑solving and critical‑thinking skills
• High attention to detail and documentation accuracy
• Ability to work cross‑functionally in a fast‑paced environment
• Commitment to patient safety and product quality

Physical and Work Environment Requirements:

• Ability to work in office, lab, and manufacturing environments
• Occasional travel for supplier audits or training
• Ability to lift up to 40 lbs
• Travel is approximately 5% with international overnight stays required
• We offer a competitive base salary and benefits.