Manufacturing Engineer - disposable, medical device high-volume production
About The Position
InnoTECH Staffing is seeking a hands-on Manufacturing Engineer to support manufacturing operations and ensure that internal assembly teams consistently deliver high-quality medical device components and finished products. Our client is a medical device manufacturer committed to advancing cancer therapy through research, engineering, high-quality products, and physician support. Candidate should live in the Boston area and be a US Citizen or Greencard holder - there is no sponsorship. Job Description You will apply your engineering expertise to the product launch and production of a novel tumor ablation system. You will work with a team of clinical, scientific, engineering, and commercial experts to manufacture, and market new therapeutic technologies.
Requirements
- BS or MS in Manufacturing Engineering, Mechanical Engineering or related engineering discipline
- 5+ years’ experience in sterile medical device high-volume production.
- Expertise in the manufacturability and qualification of disposable and reusable surgical instruments
- Experience with:
- Sterile packaging and qualification
- Fine wire soldering
- Adhesives, including UV glue
- Fixturing for hand assembly
- Writing hand-assembly procedures
- Sterile packing, including Tyvek pouches
- Heat shrinking
- Thermocouple welding
- Hypodermic and plastic tubing
- Geometric dimensioning and tolerancing
- Medical device documentation for design, risk, verification and validation, and manufacturing
- Production equipment IQ/OQ/PQ
- Ability to:
- Excellent oral and written communication skills
- Ability to carry up to 20 lbs. with or without reasonable accommodation
Nice To Haves
- Experience with the following is desirable:
- (injection) molding
- laser welding
- 3D printing
- Enclosure design
- Design for imaging compatibility (CT, MRI, PET)
- Expertise in precision design
- CAD expertise (SolidWorks preferred)
- Proficiency in medical device documentation for product launch and manufacturing
Responsibilities
- Oversee day-to-day activities within production (Cleanroom), ensuring assemblers follow approved work instructions, inspection procedures, and quality standards.
- Train assemblers and production personnel on proper assembly techniques, inspection requirements, documentation practices (DHRs, travelers), and defect recognition.
- Ensure adherence to production controls, cleanliness, calibration requirements, labeling accuracy, and workmanship standards.
- Provide hands-on support for testing, inspection, and measurement activities, including selection and validation of gauges, tools, and test equipment.
- Provide hands-on support for production equipment maintenance and repair as needed
Benefits
- We are committed to medical innovation and improving patient care.
- We value continuous improvement in product quality and functionality.
- Our team draws from decades of experience in the research, development, manufacturing, and marketing of medical devices.
- This is a full-time position with great benefits including competitive wages, medical/dental insurance, 401K, and professional development.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
