Product Development Engineer II

PMT Corporation•Chanhassen, MN

About The Position

The Product Development Engineer II leads the design, development, and continuous improvement of medical devices, accessories, and manufacturing processes for products in neurological, orthopedic, and plastic/reconstructive surgery. The role owns medium- to large-scale projects from concept through commercialization, with responsibility for product safety, effectiveness, quality, and compliance with applicable regulatory standards. It also mentors junior engineers and technicians, trains cross-functional teams, and serves as a technical resource for Sales, customers, surgeons, and suppliers. The position may require up to 10% travel to trade shows, industry events, or other relevant events.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related technical field.
At least 3–5 years of engineering experience in the medical device industry, including ownership of product development cycles.
Proficiency in SolidWorks and AutoCAD.
Strong working knowledge of MS Office and MS Project.
Demonstrated experience with project management, risk analysis (FMEA), and validation and verification methodologies.
In-depth understanding of medical device regulations, including FDA GMP and ISO 13485, and design-control processes.
Excellent communication, technical writing, and presentation skills.
Proven problem-solving and critical-thinking capabilities.
Ability to work independently and in cross-functional teams.
Experience supporting customer and supplier communications in a technical capacity.

Nice To Haves

Experience using Qualio software.

Responsibilities

Lead complex product development projects from concept through verification, validation, and production launch.
Design, develop, and optimize medical devices, accessories, and manufacturing processes in line with market needs and regulatory standards.
Develop concepts and engineering drawings using 3D CAD tools, build prototypes, and iterate designs through development.
Use engineering software to 3D-print prototypes.
Complete documentation in accordance with internal procedures, external standards, and regulations.
Document product development through required design-control stages, including design inputs and design-output verification.
Create, review, and execute design verification and validation protocols; analyze, document, and report results.
Determine sample sizes and perform statistical analysis of test data.
Manage qualification and validation testing conducted by third-party laboratories.
Plan and execute equipment qualifications (IQ, OQ, PQ) and process validations, and ensure tools and equipment are calibrated.
Generate and manage technical documentation, including change controls, design history files, instructions for use and product manuals, technical files, test validation protocols and reports, risk management files, biological evaluation plans and reports, clinical evaluation plans and reports, clinical literature reviews, and scientific notebooks.
Lead or participate in risk-management activities, including FMEA and risk assessments.
Partner with Manufacturing to develop scalable, cost-effective, user-friendly production methods and optimize procedures to reduce cost and improve quality.
Design new tooling and equipment and maintain or repair existing tooling and equipment.
Assist the manufacturing supervisor in maintaining weekly product output.
Drive root-cause analysis, corrective and preventive actions (CAPA), and resolution of complex product complaints, non-conformance reports, and product rejects, including documentation and customer responses.
Support Regulatory Affairs with FDA 510(k) submissions and other regulatory filings.
Support and participate in internal and external audits and maintain compliance with GMP, ISO 13485, FDA QSR, MDR, and the company's Quality System.
Mentor junior engineers and technicians and provide technical training to personnel on manufacturing and inspection processes.
Work with Sales, Marketing, Regulatory, and Quality to align technical deliverables with business objectives.
Provide technical support to customers and Sales representatives and attend trade shows as needed.
Design customer-requested non-standard or custom devices and communicate with surgeons and sales representatives about device requirements.
Maintain communication with strategic vendors and suppliers to support quality and timely execution of development projects.
Perform other duties and responsibilities as required; duties and activities may change.