Develops and scales manufacturing processes for complex medical devices, from project scoping and quoting through production launch. Responsibilities include schedule management, design-for-manufacturing collaboration, fabrication and assembly development, work instructions, training, inspection methods, process validation, quality documentation, and production-floor implementation. Works closely with customers, Quality, Operations, and project teams to meet milestones and improve cost and product quality.
Join Our Team at Tegra Medical!
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.
Job Summary
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
What We Offer:
- On-the-job training and advancement opportunities
- Competitive hourly wage + shift differentials (2nd & 3rd Shift)
- Great benefits like health, dental, vision, life, and disability insurance; 401K and much more.
- Paid time off, sick time and holiday pay
- Employee Assistance Program/ Tuition Reimbursement
M-F Standard Office Hours
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