Medical Device Senior Manufacturing Engineer - KLM Careers

The Medical Device Senior Manufacturing Engineer will play a crucial role in driving collaboration between R&D, Pilot, and commercial manufacturing teams from Early Human Use through to the commercialization of innovative medical devices. This position requires expertise in managing, maintaining, and improving cart systems and electromechanical devices. The Senior Manufacturing Engineer will ensure that design and manufacturing processes are characterized, robust, scalable, compliant with regulatory requirements, and validated using methodologies such as LEAN Six Sigma.

Company Culture and Environment

This role fosters a collaborative environment where cross-functional teams work closely to achieve common goals. The focus on innovation, quality, and regulatory compliance reflects a commitment to excellence in the medical device industry.

Career Growth and Development Opportunities

The position offers opportunities for professional development, including the chance to work alongside industry experts and contribute to impactful projects that enhance patient care and safety.

Detailed Benefits and Perks

While specific benefits are not detailed in the job description, roles in the medical device industry often include competitive salaries, health benefits, and opportunities for further education and training.

Compensation and Benefits

• Competitive salary based on experience
• Health, dental, and vision insurance (implied)
• Opportunities for professional development and continuous learning (implied)

Why you should apply for this position today

This is an exceptional opportunity to leverage your skills in a meaningful way within the medical device sector. You will be part of a dedicated team that is committed to innovation and patient safety. Your contributions will directly impact the development and success of new products that improve lives.

Skills

• Hands-on experience with cart systems, console operations, and electromechanical devices
• Proficient in SolidWorks with strong modeling and drawing skills
• Knowledge of DFM, Six Sigma, LEAN methodologies, and cGMP practices
• Strong analytical skills and proficiency in statistical analysis software (e.g., Minitab, JMP)
• Excellent communication skills and ability to collaborate within cross-functional teams
• Experience in design transfer, process validation, and sterilizable polymers

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
• Collaborate with contract manufacturers to develop efficient production processes
• Act as the liaison between Contract Manufacturing Organization (CMO) and Canon
• Review engineering product specifications and CAD data
• Ensure accuracy of Bill of Materials (BOM)
• Drive development and execution of experiments to validate processes
• Manage characterization and validation activities
• Maintain quality management system documentation
• Conduct pFMEA and develop process validations
• Share expertise in Lean Six Sigma

Qualifications

• Bachelor’s degree or higher in Mechanical Engineering
• 5+ years of experience in medical device manufacturing engineering
• At least three years of experience in new product development and design transfer
• Proven experience with cart systems and electromechanical devices
• Strong track record in design transfer and process validation

Education Requirements

• Bachelor’s degree in Mechanical Engineering

Education Requirements Credential Category

• Engineering degree

Experience Requirements

• 5+ years of relevant experience in medical device manufacturing engineering
• Experience in new product development, design transfer, and validating processes

Why work in Cambridge, MA

Cambridge, MA is a vibrant city known for its rich history, cultural diversity, and strong focus on innovation and technology. It is home to some of the world’s leading educational and research institutions, providing ample opportunities for networking and collaboration. The city offers a lively atmosphere with a range of dining, entertainment, and recreational options, making it an attractive place to live and work.

Employment Type: Contractor

Education Level: Bachelor's degree

Qualifications: 1. Do you have a bachelor’s degree or higher in Mechanical engineering. 2. Do you have 5+ years of experience in medical device manufacturing engineering, Do you have including at least three years in new product development, design transfer to production, and validating processes. 3. Do you have experernce werking with cart systems, console operations, and electromechanical devices. This includes hands-on experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment. 4. Do you have excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts. 5. Do you have experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred. 6. Do you have a proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques. 7. Do you have technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation. 8. Do you have proficient in SolidWorks with experience in tool and fixture design. 9. Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement 10. Do you have Lean and/or Six Sigma certifications. - Nice to have: 11. Must be a US Citizen or Green Card holder.