NPI Process Development Engineer

Tegra Medical; Franklin (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

On-the-job training and advancementOp

Competitive hourly wage + shift differ

Great benefits like health, dental, v…

Paid time off, sick time and holiday

Employee Assistance Program/ Tuition

Job summary

Tegra Medical is seeking a Product Development Engineer (PDE) to turn great designs into reliable medical devices. You will work on devices used in cardiac surgery, neuro implants, and sports medicine, collaborating with customers and Tegra teams to optimize manufacturability.

You will define scope, estimate processes and NRE, develop schedules, and ensure milestones with Quality and Operations. The role requires 4+ years engineering, a mechanical/industrial degree, and SolidWorks proficiency;

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

Customer negotiation

Attention to detail

ISO 13485 experience

IQ/OQ/PQ

SolidWorks

Education

Bachelor's degree in mechanical or industrial engineering

Tools

SolidWorks

Job 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)
• SolidWorks training

Physical Requirements:

• Frequent performing repetitive work
• Frequent safety clothing required (safety glasses)
• 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& 3rdShift)
• 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