Product Development Engineer II

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PMT Corporation located in Chanhassen Minnesota is known for manufacturing and distributing high end innovative products within the Orthopedic Neurosurgery and Plastic Surgery markets. Our workplace is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together we celebrate successes learn from challenges and continuously evolve in our pursuit of excellence.

Join us at PMT Corporation if youre ready to be a part of a collaborative idea-driven and communicative environment. Your innovation matters and together we can continue to shape the future of the medical device industry.

PRODUCT DEVELOPMENT ENGINEER II OVERVIEW:

As a Product Development Engineer II you will play a key role in the design development and continuous improvement of innovative medical devices and accessories. You will take ownership of medium- to large-scale projects from concept through commercialization while mentoring junior engineers and collaborating cross-functionally with internal teams and external stakeholders. You will apply your technical expertise regulatory knowledge and problem-solving skills to ensure the development of safe effective and high-quality medical products.

COMPETANCIES & RESPONSIBILITIES:

Lead and manage complex product development projects from concept through validation and production launch.

Design develop and optimize innovative medical devices accessories and manufacturing processes that align with market needs and regulatory standards.

Create and execute product verification and validation protocols; analyze and document results.

Generate and manage technical documentation including Engineering Change Orders (ECOs) design history files test reports and risk assessments.

Use 3D CAD tools (e.g. SolidWorks AutoCAD) to develop design concepts and engineering drawings; prototype and iterate designs through various phases of development.

Collaborate with manufacturing to develop scalable cost-effective and user-centric production methods.

Drive root cause analysis corrective actions and resolution of complex product issues and complaints.

Support and participate in internal and external audits ensuring compliance with GMP ISO 13485 FDA QSR and other applicable regulatory standards.

Mentor and support junior engineers and technicians; provide technical training across cross-functional teams.

Interface with key stakeholders including Sales Marketing Regulatory and Quality to align technical deliverables with business objectives.

Maintain communication with strategic vendors and customers to ensure quality and timely execution of development projects.

QUALIFICATIONS:

Bachelors degree in Mechanical Engineering Biomedical Engineering Chemical Engineering or related technical field.

Minimum 35 years of engineering experience in the medical device industry including ownership of product development cycles.

Proficient in SolidWorks and AutoCAD; strong working knowledge of MS Office and MS Project.

Demonstrated experience with project management risk analysis (FMEA) and validation/verification methodologies.

In-depth understanding of medical device regulations (FDA GMP ISO 13485) and design control processes.

Excellent communication technical writing and presentation skills.

Proven problem-solving and critical thinking capabilities.

Self-motivated and capable of working independently and within cross-functional teams.

Experience supporting customer and supplier communications in a technical capacity.

Medical Surgical Laboratory Research/Equipment and Supplies Cosmetic

CONFIDENTIAL EQUAL OPPORTUNITY EMPLOYER

JOB CODE: PDEIIJun25