Process EngineerJob 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.
