Process Engineer

                                  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.

Competencies:

• 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
• Continuous improvement mindset

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 & Benefits

• Travel is approximately 5% with international overnight stays required
• We offer a competitive base salary and benefits.