Senior Manufacturing Engineer
About The Position
The Senior Manufacturing Engineer provides technical leadership for manufacturing processes, equipment, and product transfers supporting development, commercialization, and sustaining operations. The role develops, implements, and continuously improves manufacturing processes to ensure product quality, regulatory compliance, operational efficiency, and scalability. It serves as a subject matter expert for complex manufacturing challenges, leads cross-functional improvement initiatives, and provides technical guidance to manufacturing, quality, supply chain, and product development teams. The position operates with limited supervision and independently manages significant projects while influencing practices and decisions within a product line or manufacturing area. The role leads process development, qualification, optimization, and improvement; establishes process controls, tooling strategies, operating parameters, and validation approaches; and supports planning and improvements across development, transfer, launch, and sustaining activities. It leads process characterization, design of experiments, process capability assessments, manufacturing transfers, scale-up, readiness assessment, and production ramp-up. It also leads complex manufacturing investigations and corrective actions, defines equipment and tooling requirements, and leads equipment and process qualification, including IQ, OQ, and PQ. The Senior Manufacturing Engineer coordinates technical alignment across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D; represents Manufacturing Engineering in reviews and leadership discussions; and mentors engineers and technicians. The role develops and maintains manufacturing documentation and supports quality-system compliance, change control, risk management, process validation, and audit readiness.
Requirements
- Bachelor of Science in an engineering discipline, such as Industrial or Mechanical Engineering.
- At least 6 years of medical device manufacturing experience; advanced degrees in engineering, biomedical sciences, or related fields may be considered for reduced experience requirements.
- SolidWorks experience.
- Experience with equipment, tooling, and fixture design.
- Experience with root cause analysis and problem-solving tools for technical and process issues.
- Knowledge of Lean and Six Sigma tools.
- Working knowledge of cGMP requirements for medical device manufacturing under FDA QSR and ISO 13485.
- Ability to stand, walk, sit, talk or hear, use hands to handle objects or controls, reach, and stoop, kneel, bend, or crouch; ability to lift up to 20 pounds.
- Vision abilities including close vision, distance vision, depth perception, color vision, and ability to adjust focus.
Nice To Haves
- Advanced degree in engineering, biomedical sciences, or a related field.
Responsibilities
- Lead development, qualification, optimization, and continuous improvement of manufacturing processes.
- Establish and maintain process controls, tooling strategies, operating parameters, and validation approaches to ensure consistent product quality and performance.
- Provide technical leadership and support to manufacturing operations for process capability, efficiency, and compliance initiatives.
- Support manufacturing planning and process improvements across development, transfer, launch, and sustaining activities.
- Lead manufacturing process development and optimization to meet quality, cost, delivery, and regulatory requirements.
- Define and execute process characterization studies, design of experiments (DOE), and process capability assessments.
- Provide manufacturing expertise during product development to support design for manufacturability, scalability, and robust process performance.
- Collaborate with cross-functional teams to incorporate manufacturing requirements into product and process designs.
- Lead manufacturing transfers from development to production and between manufacturing sites or contract manufacturers.
- Develop and execute qualification plans, readiness assessments, and production ramp-up activities.
- Engage with contract manufacturing partners to align manufacturing and quality requirements.
- Establish transfer criteria and manufacturing readiness requirements for new products and processes.
- Lead investigations and resolution of complex manufacturing issues, non-conformances, and process deviations.
- Define corrective actions and risk mitigation strategies for recurring or systemic manufacturing issues.
- Implement improvements that enhance yield, reliability, throughput, and process robustness.
- Use data-driven approaches to identify and execute continuous improvement opportunities.
- Define requirements and specifications for manufacturing equipment, tooling, fixtures, and automation systems.
- Lead equipment and process qualification, including IQ, OQ, and PQ protocols and execution.
- Ensure manufacturing processes and systems remain validated and compliant.
- Support capital equipment selection, implementation, and lifecycle management.
- Lead technical alignment across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D.
- Represent Manufacturing Engineering in design reviews, program reviews, change control reviews, and leadership discussions.
- Mentor Manufacturing Engineers, Technicians, and cross-functional team members in manufacturing best practices and problem-solving methodologies.
- Coordinate cross-functional efforts to achieve project and operational objectives.
- Develop and maintain manufacturing documentation, including procedures, work instructions, validation protocols, reports, and technical assessments.
- Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality-system procedures.
- Support change control, risk management, process validation, and audit readiness activities.
- Drive consistent application of engineering, validation, and quality-system practices.
- Provide technical leadership, mentorship, and direction to Manufacturing Engineers, Process Technicians, and Manufacturing Technicians.
- Lead project teams or coordinate technical activities across functional groups as needed.
Benefits
- Medical, dental, and vision insurance at no cost for employee-only coverage.
- 401(k) matching plan.
- Paid time off starting at three weeks per year.
- Competitive salary and opportunities for career growth.
- Employee stock options.
- Life and AD&D insurance and long-term disability insurance.
- Education assistance.
- Voluntary commuter benefits and pet insurance.
- Weekly company lunches and occasional happy-hour events.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
