NPI Process Development Engineer at Tegra Medical Holdings LLC

Franklin, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Aug, 26

Salary

100000.0

Posted On

21 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, NPI, Medical Device Manufacturing, ISO 13485, Process Validation, IQ/OQ/PQ, SolidWorks, Microsoft Project, Project Scheduling, Design For Manufacturing, Negotiation, Interpersonal Skills

Industry

Medical Equipment Manufacturing

Description

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

Responsibilities

The PDE is responsible for turning designs into manufacturable medical devices by developing processes, managing project schedules, and collaborating with customers. They handle hands-on fabrication, assembly, and the creation of validation protocols to drive projects to scaled production.