Principal Medical Device New Product Development Lead

ProMed Molded Products, Inc.; Plymouth (MN); Hybrid; USD 144,000 - 199,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Vision Insurance

Life Insurance

Paid Family Medical Leave

Long-Term Disability Insurance

Hospital Indemnity

Critical Illness

Pet Insurance

Job summary

ProMed Molded Products, Inc. is seeking a Principal New Product Development Project Engineer to serve as the project owner—responsible from strategy through delivery in a regulated medical device environment.

You will translate customer needs into realistic plans within ProMed's manufacturing setting, balancing cost, schedule, quality, and risk while guiding teams and mentoring other engineers. The role emphasizes driving engineering design and development, achieving on-time, within-budget

Qualifications

• Working knowledge of English, both verbal and written.
• Minimum 10 years' engineering experience; advanced degree preferred.
• Experience with medical device development or highly regulated manufacturing environments.
• Ability to work independently with multiple priorities and deadlines.

Responsibilities

• Owns projects from strategy through delivery in a regulated environment.
• Lead technical teams, mentor engineers and project managers.
• Coordinate with customers to translate requirements into feasible plans.
• Develop timelines, cost estimates, and resource plans.
• Ensure quality systems, documentation, and regulatory compliance are maintained.

Skills

Engineering Design

Medical Device Development

ISO 13485

Cross-Functional Leadership

Technical Communication

Risk Assessment

Customer Relationship Mgmt

Cost Estimation

Design for Manufacturing

Mold Design

Verification & Validation

Documentation

Mentoring

Budgeting

Regulatory Compliance

Education

BS in Engineering or Physical Science

MS in Engineering/Related Field (advantageous)

Job description

ProMed Molded Products, Inc. is seeking a Principal New Product Development Project Engineer to serve as the project owner—responsible from strategy through delivery in a regulated medical device environment.

You will translate customer needs into realistic plans within ProMed's manufacturing setting, balancing cost, schedule, quality, and risk while guiding teams and mentoring other engineers. The role emphasizes driving engineering design and development, achieving on-time, within-budget