Fractyl
Principal Manufacturing Engineer
Burlington, MA · Principal
Sponsorship not specified$115k-$165kDetected 124 days ago
StatisticsSupply ChainSolidWorksPCB DesignFDA RegulatoryMedical DevicesLeadershipProblem SolvingWriting
About the role
- The Principal Manufacturing Engineer is a hands-on technical leader responsible for new product introduction and for defining, validating, and sustaining robust manufacturing processes for electromechanical medical devices.
- Serve as a technical authority for manufacturing process development and validation of electromechanical products.
- Ensure all validation activities comply with FDA, ISO 13485, and applicable regulatory standards.
Responsibilities
- Develop and maintain Master Validation Plans (MVPs) covering equipment, processes, software, and test methods.
- Analyze data trends to establish control strategies and drive continuous process improvements.
- Support regulatory submissions, audits, and inspections.
- Support new product introduction (NPI), design transfer, and sustaining engineering activities.
- Collaborate cross-functionally with R&D, Quality, Supply Chain, and Operations.
Requirements
- Bachelor's degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related field.
- Minimum of 10 years of manufacturing engineering experience in a regulated environment.
- Expertise in electromechanical manufacturing processes (PCB assembly, cable/harnessing, machining, sheet metal).
- Strong statistical analysis and validation experience.
- Knowledge of regulatory requirements for medical devices.
- Experience with single-use device processes is desirable.
- Strong technical writing and documentation skills.
- Ability to manage projects and work cross-functionally.
- Strong technical leadership and problem-solving skills.
- Excellent written and verbal communication.
- High attention to detail.
- Collaborative and proactive mindset.
Nice to have
- Working knowledge and experience with the processes associated with single use devices (adhesive bonding, thermal welding, injection molding and extrusion) would be considered a strong plus.
- Experience with SolidWorks and Minitab preferred.
- Familiarity with schematic tools (e.g., OrCAD) is a plus.
Skills
- Qualifications and Skills
Compensation
- This position offers a competitive salary in the range of $115,000 - $165,000 annually, along with a comprehensive benefits package.
- Actual compensation will be based on relevant experience, education, and market factors.
- In accordance with Massachusetts law, General Laws Chapter 149, Section 19B.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
- An employer who violates this law shall be subject to criminal penalties and civil liability.
- Lead development and execution of manufacturing, test, and validation strategies aligned with regulatory requirements, product risk, and business objectives.
Benefits
- Medical device experience preferred (ISO 13485, ISO 14971).
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