Principal Manufacturing Engineer

Goddard Technologies, Inc.; Beverly (MA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

A leading company in transformative technology is seeking a Principal Manufacturing Engineer to lead new product introductions and drive manufacturing readiness. This role involves overseeing process development and ensuring quality compliance, with opportunities for mentorship and collaboration across teams. The ideal candidate will have extensive experience in regulated environments and strong leadership skills, making a significant impact on the company's innovative solutions.

Benefits

Flexible time off

401(k) retirement plan with 3% contribution

Comprehensive health coverage with 80% premium contribution

6 weeks fully paid parental leave

Regular company engagement events

Qualifications

• Minimum 12 years in regulated medical device manufacturing.
• Lean Six Sigma certification or experience preferred.
• Experience with injection molding and joining technologies.

Responsibilities

• Lead design for manufacturability and assembly activities.
• Ensure compliance with FDA QSR and ISO 13485.
• Mentor junior engineers and drive process validation.

Skills

Process Development

Statistical Analysis

Leadership

Project Management

Collaboration

Education

Bachelor’s degree in Manufacturing, Mechanical Engineering or related discipline

Tools

SolidWorks

Minitab

Job description

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed – it’s all about solving the most complex challenges by creating transformative technology.

Our Culture and People:

At Goddard, our most important asset is our people. We don't just work together; we thrive together. We foster a culture of collaboration, continuous learning, and mutual support. We believe in taking exceptionally good care of each other because great teams build great solutions. If you are someone who embodies the values of accountability, inspiration, dedication, efficiency, innovation, integrity, quality, and reliability, we want you on our team. Come be a part of a workplace where your ideas are valued, your growth is encouraged, and your contributions make a real impact. Join us in shaping the future of transformative technology – together.

The Role:

The Principal Manufacturing Engineer, focusing on New Product Introduction (NPI), is responsible for leading high-level process development and manufacturing readiness for new product introductions. This role serves as a technical expert and mentor, driving strategic initiatives in manufacturing engineering with minimal supervision. This role will ensure that manufacturing processes are designed, validated, and executed to meet quality, scalability, and operational efficiency goals.

Responsibilities:

Design & Development

• Lead Design for Manufacture (DFM) and Design for Assembly (DFA) activities during product development and enhancement programs.
• Serve as the technical lead in Process Failure Modes and Effects Analysis (PFMEA) development with cross-functional teams.
• Develop CTQ (Critical to Quality) and CTA (Critical to Assembly) requirements.
• Generate and validate manufacturing documentation including work instructions and test procedures.
• Specify, design, and install production equipment, tooling, and fixtures.

Process & Equipment Qualification

• Lead development and qualification of robust manufacturing processes to ensure efficiency and scalability.
• Drive process validation including MSA, Gage R&R, SPC, and process capability analysis.
• Oversee the implementation and qualification of automation and assembly equipment (IQ, OQ, PQ).

Quality Assurance & Compliance

• Ensure all processes comply with FDA QSR and ISO 13485 requirements.
• Support internal and external design teams in successful design transfer activities.
• Lead risk analysis, non-conformance resolution, and continuous improvement initiatives.

Operations Support

• Develop and implement strategic manufacturing plans to support production goals.
• Analyze process metrics and KPIs to drive improvements in yield, quality, and efficiency.
• Mentor junior staff and provide technical leadership within the engineering team.

Cross-functional Collaboration

• Collaborate with R&D, Quality, and Supply Chain to align engineering and manufacturing objectives.
• Communicate program updates and process strategy to senior leadership.
• Support broader company initiatives as a senior member of the manufacturing organization.

Qualifications:

• Bachelor’s degree preferred in Manufacturing, Mechanical Engineering or related engineering discipline.
• Minimum 12 years of experience in regulated medical device manufacturing environments.
• Expertise in process development for both disposables and capital equipment.
• Proven experience in selection, qualification, and implementation of automation and assembly systems.
• Skilled in SolidWorks for 3D modeling and tooling/fixture design.
• Strong statistical analysis skills with experience in Minitab or similar tools.
• Experience with injection molding and joining technologies including ultrasonic, RF, and laser welding.
• Lean Six Sigma certification or experience strongly preferred.
• Strong leadership and project management capabilities.
• High attention to detail and commitment to quality.
• Proven mentoring ability and cross-functional collaboration experience.

#LI-Hybrid

Flexible Time Off: Benefit from our generous flexible time off policy. We also provide sick leave and bereavement time because we understand that not all time off is for fun.

Retirement Savings: Invest in your future with a 401(k)-retirement plan. Goddard contributes 3% of your annual salary directly into your 401(k) account—regardless of your own contributions.

Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family. Goddard contributes 80% of monthly premiums for all medical plan options.

Family Support: To take the time you need to welcome the newest member of your family, Goddard offer 6 weeks fully paid parental leave with support of PFML state programs.

Company Engagement: Engage with your colleagues through a variety of regular company and team events, including weekly social hours, Athletic Club outings, and department outings.