Support production performance targets for safety, quality, delivery, and cost.
Manufacturing Process Development & Optimization
Develop and optimize manufacturing processes to improve capability, reliability, quality, and productivity.
Establish process controls and monitoring strategies.
Conduct process characterization and capability analysis.
Identify opportunities for process automation, error-proofing, and waste reduction.
Support capacity and line balancing initiatives to meet business demand.
Validation & Compliance
Develop and execute validation activities including: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)
Ensure manufacturing processes remain in a validated state.
Support risk management activities including PFMEA and process risk assessments.
Maintain compliance with: ISO 13485 FDA QSR GMP Internal Quality System requirements.
Continuous Improvement
Lead Lean Manufacturing and Continuous Improvement projects.
Identify and implement opportunities to: Improve yield Reduce scrap Reduce downtime Increase productivity Improve ergonomics
Develop fixtures, tooling, and automation solutions to improve process robustness.
Utilize engineering and statistical tools to support decision-making.
Cross-Functional Collaboration
Collaborate with: Production Quality Engineering Product Development Supply Chain Supplier Quality Global Engineering teams
Support audits, inspections, and compliance activities.
Provide technical mentoring to graduate engineers, technicians, and interns.
Participate in global engineering initiatives and technology transfer programs.
Qualifications
Required
Bachelor's Degree in: Mechanical Engineering Manufacturing Engineering Mechatronics Engineering Biomedical Engineering Industrial Engineering Or related discipline
Minimum 2-4 years of Manufacturing Engineering experience within a regulated manufacturing environment.
Experience with process validation (IQ/OQ/PQ).
Experience supporting production and manufacturing operations.
Strong root cause analysis and troubleshooting skills.
Preferred
Medical device manufacturing experience.
Knowledge of ISO 13485, FDA QSR, and GMP requirements.
Experience with statistical tools and process capability analysis.
Lean Manufacturing and Six Sigma knowledge.
Experience supporting global product transfers and manufacturing scale-up activities.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
