Project Manager, Product Engineer, Biomedical Engineer

Job Description:

The Program Manager leads the execution of one or more concurrent medical device product development programs from concept through commercialization. This role combines technical leadership with full program ownership, ensuring that product development projects meet cost, schedule, quality, and performance objectives. The position manages a portfolio of development programs, coordinates cross-functional teams, and serves as a primary point of contact for internal stakeholders and external partners throughout the product development life cycle.

Responsibilities:

* Own full-cycle development project plans and deliverables for one or more simultaneous medical device products under development.

* Lead multi-departmental, cross-functional teams through the complete product development life cycle, from early concept and feasibility through verification, validation, and commercialization.

* Track project progress and milestones, analyze variances, and develop and implement recovery plans when deviations from cost, schedule, or performance targets occur.

* Maintain overall accountability for program costs, schedules, and performance, ensuring alignment with organizational goals and regulatory requirements.

* Serve as the primary liaison to key stakeholders, providing timely and transparent updates on project milestones, risks, issues, and overall progress.

* Report team progress and recommendations on a regular basis, including risk mitigation strategies and resource needs.

* Lead core team meetings, set clear objectives, define priorities, and document decisions, action items, and outcomes.

* Apply appropriate project management techniques and methodologies tailored to the specific needs, risks, and complexity of each program.

* Resolve cross-functional barriers, facilitate effective collaboration, and delegate tasks appropriately across engineering, operations, quality, and other functions.

* Collaborate with functional leaders to address resource constraints, balance workloads, and ensure that project teams have the support needed to meet deliverables.

* Serve as a hands-on technical resource throughout the project, contributing to engineering decisions and problem-solving activities.

* Perform investigational and early verification testing to assess design feasibility, performance, and reliability.

* Evaluate and resolve project issues impacting manufacturability, reliability, and product performance, working closely with design, process, and manufacturing engineering.

* Engage with vendors and external partners for equipment, components, and services, ensuring that technical and quality requirements are clearly defined and met.

* Utilize rapid prototyping, machine shop tools, and molding and extrusion methods to support design iteration, prototyping, and process development.

* Ensure that department and organizational needs are incorporated into development plans, including considerations for research and development, design engineering, process development, and commercial manufacturing.

* Support and promote adherence to applicable medical device regulations and standards throughout the product development life cycle.

* Contribute to continuous improvement of project management and product development processes by sharing lessons learned and best practices.

Essential

Skills:

* Proven ability to lead medical device product development as a technical lead or principal engineer.

* Demonstrated experience managing cross-functional teams through the full product development life cycle in a regulated medical device environment.

* Minimum of ten years of previous engineering experience, preferably in medical device product development.

* Minimum of seven years of project management experience in a regulated medical device environment.

* Strong project management skills, including planning, scheduling, cost control, risk management, and project coordination.

* Hands-on technical expertise in research and development, design engineering, or process development.

* Experience with product development life-cycle management and program management for complex technical products.

* Ability to serve as the primary liaison to stakeholders, delivering clear, timely updates on risks, milestones, and progress.

* Knowledge of Quality System Regulation (QSR) CFR 820 and applicable ISO standards relevant to medical devices.

* Experience working in CMO/CDMO medical device environments or similar contract development and manufacturing settings.

* Strong skills in customer and vendor management, including communication, negotiation, and relationship building.

* Ability to evaluate and resolve issues impacting manufacturability and reliability of medical devices.

* Proficiency in applying engineering principles to support investigational and early verification testing.

* Bachelor of Science degree in Engineering or a closely related technical discipline.

Job Type & Location

This is a Permanent position based out of Brooklyn Park, MN.

Pay and Benefits

The…