NPI Process Engineer — Medical Devices, On-the-Job Training

Tegra Medical; Country View Estates (MA); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

On-the-job training

Shift differentials

Health insurance

Dental insurance

Vision insurance

401K

Paid time off

Tuition reimbursement

Employee assistance program

Job summary

Tegra Medical in Franklin, MA is seeking a NPI Process Development Engineer to translate advanced designs into manufacturable medical devices. PDEs collaborate with customers to optimize processes, reduce costs, and ensure quality from prototype to production.

You will work in a global team on projects across cardiac, neuro, and sports medicine, leading process validation, timelines, and production scaling to GMP-compliant manufacturing.

Qualifications

• Four or more years of engineering experience.
• Bachelor’s degree in mechanical or industrial engineering, or equivalent experience.
• Great interpersonal and negotiation skills, particularly when working with customers.
• The ability to be relied on as a key team member.
• An eye for details and a passion for perfection.
• Experience with medical devices and/or ISO 13485 quality standards.
• Process validations (IQ/OQ/PQ requirements).
• SolidWorks training.

Responsibilities

• Work in a high visibility job in a global company, collaborating with people at all levels and functions within Tegra Medical and with our customers.
• Help define the project scope and support project quoting, including process, material, and NRE estimation.
• Develop, drive, and support the project schedule to maintain adherence to objectives and commitments.
• Work collaboratively with Quality and Operations to develop, gain support, and meet project milestones.
• Support hands-on development activities related to fabrication and assembly of customer products. This includes the creation of work Instructions, training requirements, and inspection methods.
• Assist in the development and completion of required validation protocols, reports, and other quality activities and documentation.
• Work through Tegra Medical’s program management system and drive projects to scaled production volumes.
• Become a trusted member of the development team, working closely with the customer engineering team as you collaborate on refining their design for manufacturing.
• Roll up your sleeves and put on your safety glasses as you put your ideas into action on the production floor.
• There may be additional duties and responsibilities in this dynamic environment.

Skills

Engineering experience

Interpersonal skills

Team player

Attention to detail

IQ/OQ/PQ

Education

Bachelor's degree in Mechanical or Industrial Engineering

Tools

SolidWorks

Job description

Tegra Medical in Franklin, MA is seeking a NPI Process Development Engineer to translate advanced designs into manufacturable medical devices. PDEs collaborate with customers to optimize processes, reduce costs, and ensure quality from prototype to production.

You will work in a global team on projects across cardiac, neuro, and sports medicine, leading process validation, timelines, and production scaling to GMP-compliant manufacturing.