Medical Device Senior Manufacturing Engineer
hace 7 días
The Senior Manufacturing Engineer will play a critical role in fostering collaboration between R&D, Pilot, and commercial manufacturing phases to contribute from Early Human Use to the commercialization of new medical products. This position will ensure that design and manufacturing processes are characterized, robust, scalable, and compliant with regulatory requirements while utilizing the best technologies and methodologies such as LEAN Six Sigma and Design for Manufacturing.
Compensation and Benefits
- Competitive salary based on experience
- Health, dental, and vision insurance
- Retirement savings plan with company matching
- Generous vacation and paid time off policy
- Flexible working hours
- Opportunities for professional development and continuous learning
- Remote work options available
Why you should apply for this position today
This is an outstanding opportunity to join a dynamic team dedicated to improving medical device manufacturing processes. You will have the chance to work on innovative projects that significantly impact patient care while collaborating with esteemed professionals in the field.
Skills
- Strong knowledge of cart systems, console operations, and electromechanical devices
- Proficient in SolidWorks for modeling and drawing
- Experience with contract manufacturers and capital equipment
- Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation
- Ability to conduct pFMEA and develop process validations
- Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP
- Lean and / or Six Sigma certifications are a plus
Responsibilities
- Develop and optimize manufacturing processes for medical devices
- Produce production-level assembly and part drawings
- Incorporate DFM, Six Sigma, and LEAN principles into designs
- Identify and evaluate contract manufacturing partners
- Liaise between Contract Manufacturing Organization (CMO) and Canon
- Review engineering specifications and CAD data
- Manage part / drawing release and BOM accuracy
- Execute experiments and tests on product lines
- Conduct Characterization and Validation activities
- Create and maintain manufacturing documentation
- Coordinate technical communications
Qualifications
- Bachelors degree or higher in Mechanical Engineering
- 5+ years of experience in medical device manufacturing engineering
- At least three years in new product development and production design transfer
- Proven track record in design transfer and process validation
- Experience in troubleshooting and optimizing electromechanical systems
- Strong modeling skills in SolidWorks
Education Requirements
- Bachelors degree in Mechanical Engineering or a related field
Experience Requirements
- Minimum of 5 years in medical device manufacturing
- Experience in managing and improving cart / console systems
- Familiarity with sterilizable polymers and catheter fabrication techniques
Why work in Cambridge, MA
Cambridge is a hub of innovation and collaboration, home to many leading universities and research institutions. The vibrant atmosphere fosters creativity and growth, with a strong focus on technology and health care. The city offers a rich cultural experience, diverse dining options, and ample opportunities for professional networking and advancement, making it an ideal place for your career development.
Employment Type : Full-Time
Education Level : Bachelor's degree
Required Knowledge, Skills, and Abilities :
- Do you have a bachelors degree or higher in Mechanical engineering?
- Do you have 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes?
- Do you have experience working with cart systems, console operations, and electromechanical devices, including hands-on experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment?
- Do you have excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts?
- Do you have experience working with contract manufacturers / vendors for capital equipment, electronics testing, and/or catheter manufacturing?
- Do you have a proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques?
- Do you have technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation?
- Are you proficient in SolidWorks with experience in tool and fixture design?
- Are you highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement?
- Do you have Lean and/or Six Sigma certifications?
- Must be a US Citizen or Green Card holder.
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