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
M-F Standard Office Hours
Skills Required
- Four or more years of engineering experience
- Bachelor’s degree in mechanical or industrial engineering, or equivalent experience
- Strong interpersonal and negotiation skills, particularly when working with customers
- Ability to serve as a reliable key team member
- Attention to detail and commitment to high-quality work
- Experience with medical devices and/or ISO 13485 quality standards
- Experience with process validations, including IQ/OQ/PQ requirements
- Experience with Microsoft Project and Gantt charts
- SolidWorks training
What We Do
Tegra Medical is an end-to-end contract manufacturing solutions provider, known as the company “where medical devices come to life.” Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. Our headquarters is in Franklin, Massachusetts and we have manufacturing locations in Massachusetts, Mississippi, Costa Rica, Europe, and Asia. We are ISO 13485 and FDA registered. Tegra Medical is a member of SFS. We often have open job positions for skilled manufacturing positions. Please see https://www.tegramedical.com/careers/ for our latest job openings.
