Senior Manufacturing Engineer

Our Mission:

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 Senior Manufacturing Engineer will lead process development and manufacturing readiness for new product introductions (NPI), including both disposables and capital equipment. This role requires hands-on technical expertise in manufacturing engineering, automation, and cross-functional collaboration. The ideal candidate will be a key contributor to product commercialization efforts, ensuring manufacturing processes meet quality, efficiency, and scalability goals.

Responsibilities:

Design & Development

• Collaborate with R&D and Quality teams to support Design for Manufacturing (DFM) and Design for Assembly (DFA) activities during product development.
• Lead Process Failure Modes and Effects Analysis (PFMEA) in coordination with cross-functional teams.
• Develop Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements to guide robust process design.
• Create and maintain work instructions, test procedures, and technical documentation.
• Specify, design, and install assembly equipment, tooling, and fixtures.

Process & Equipment Qualification

• Lead efforts to identify, implement, and validate manufacturing processes for new products.
• Conduct Measurement System Analysis (MSA), including Gage R&R and Statistical Process Control (SPC).
• Drive equipment qualification (IQ, OQ, PQ) and ensure production readiness.

Quality Assurance & Compliance

• Partner with Quality and Product Development to ensure processes meet FDA and ISO 13485 requirements.
• Drive continuous improvement initiatives through data analysis and root cause problem-solving.
• Represent Manufacturing Engineering in internal and external design transfer activities.

 Operations Support

• Identify and implement scalable manufacturing strategies that support capacity, quality, and cost targets.
• Analyze key performance indicators and process capability metrics to inform decisions.
• Provide technical leadership to cross-functional teams and support process training for production staff.

Cross-functional Collaboration

• Act as a primary manufacturing liaison in product development projects.
• Support Supply Chain, Quality, and Operations in vendor evaluations and production planning.
• Communicate effectively with leadership and contribute to strategic manufacturing initiatives.

Qualifications:

• Bachelor’s degree preferred in Manufacturing, Mechanical Engineering or related engineering discipline.
• Minimum 5 years’ experience in medical device or regulated manufacturing environment.
• Demonstrated experience in NPI manufacturing, including process development for both disposables and capital systems.
• Expertise in automati