Manufacturing Engineer

Hands-On Engineering (Primary Focus)

Perform extensive hands-on work, including prototyping, lab activities, assembly troubleshooting, and machine shop tasks.
Support a wide range of manufacturing processes, including:

Precision assembly of micro-surgical devices
Fiber-optic assembly and handling
Basic machining and shop-based fabrication (traditional, non-CNC)
Light tooling and fixture fabrication

Provide fast-cycle, short-term engineering support and "quick hit" fixes to keep production moving.
Modify or influence manufacturing processes where higher-end assembly skills are required.

Mechanical Design:
Use CAD tools (Autodesk Inventor preferred, but Solid Works or similar is acceptable) to support mechanical design when needed.
CAD will be used as a tool-not the primary responsibility.

Process Development & Validation:
Conduct process development for hand-built medical products.
Author and execute validation protocols (IQ/OQ/PQ).
Support risk management and CAPA activities; prior experience is a plus but can be trained.
Work under ISO 13485 and MDR requirements; experience helpful but not mandatory.

Documentation & Compliance:
Produce extensive engineering documentation; format and templates are specific to the company and will be trained.
Participate in internal and external audits.
Support Part 11 assessments for validated software.

Team & Work Environment:
Join a small, collaborative engineering team of three.
Work closely with design engineering (Jim) and manufacturing.
Balance of office work and floor time (heavy floor presence).

Ideal Candidate Profile:
Strong hands-on mindset with personal projects or hobbies demonstrating mechanical aptitude.
Comfortable spending ~80% of time doing physical, practical engineering work.
Mechanical design background strong enough to understand basic principles and use CAD, but not necessarily a design-heavy engineer.
Experience in medical devices is helpful but not required. General manufacturing backgrounds are welcome.
Learns best by doing; thrives in an environment where many products are hand-built and require engineering creativity.
Adaptable and excited by short-cycle, fast-paced tasks rather than long multi-year R&D projects.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

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Required Skills & Experience

Experience with mechanical design work and knowledge in manufacturing processes
Lead the design efforts for manufacturing processes used to manufacture single use disposable products.
Someone who wants to be hands-on mechanical aptitude - at least 70-80% of prior roles involving prototyping, assembly support, troubleshooting, or shop work.
Experience supporting manufacturing or production environments, especially hand-built or precision assembly processes.
Mechanical engineering degree with 1-3 years of industry experience.
CAD proficiency (Inventor preferred, but Solid Works or similar acceptable) used as a tool, not the primary function.
Strong documentation skills including writing protocols, test reports, or process documentation in a regulated or structured environment.
Basic understanding of process validation (IQ/OQ/PQ) OR demonstrated ability to learn it quickly.
Comfort working with small, high-precision components, ideally with fiber optics, micro-mechanisms, or fine detail…