NPI Process Development Engineer

We’re a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others can’t, we pride ourselves on precision and innovation. Headquartered in Franklin, MA, Tegra Medical is part of the global SFS Group, based in Heerbrugg, Switzerland. Together, we’re shaping the future of healthcare.

PDEs turn great designs into great products. Customers love our PDEs because they find ways to lower their manufacturing costs and make better quality products. They are experts in the science of efficient manufacturing and the art of using their “soft skills” – working closely with customers to negotiate and refine the tiniest details. In short, they know how to figure out the smartest way to manufacture a medical device and how to influence and guide colleagues, management, and customers.

As a PDE you might find yourself working on ground-breaking devices from head to toe including those for cardiac surgery, neuro implants, and sports medicine.

Role and 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.

Level of Skill, Education and Experience

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)

Microsoft Project (Gantt charts)

SolidWorks training

Physical Requirements:

Frequent performing repetitive work

Frequent safety clothing required (safety glasses)

Constant PPE gowning

Occasional lifting (max. 40 lbs.)

Occasional carrying (max. 40 lbs.)

Subject to physical hazards from moving equipment and machine parts

Frequent standing

Occasional sitting, walking, pushing, pulling, reaching