The Product Development Engineer designs and develops innovative medical device products, guiding them from initial concept through to market release while ensuring compliance with regulatory and quality standards. This role involves close collaboration with cross-functional teams and a hands-on approach to continuous improvement and operational excellence.

Responsibilities

• Support and participate in design, testing, modification, fabrication, and assembly of prototypes with detailed documentation.
• Utilize CAD software and drafting tools for product design work.
• Determine design specifications and perform necessary adjustments and calibrations.
• Investigate existing technologies and develop new methodologies, materials, and processes.
• Support product development plans including schedule adherence, cost management, and design input fulfillment.
• Review customer prints for accuracy of product specifications, geometry, dimensions, and quality standards.
• Provide cost estimates and time standards for manufacturing operations aligned with engineering and production requirements.
• Conduct quality checks on all documents and reports to verify data accuracy and completeness.
• Create manufacturing Bills of Materials to support manufacturing, quality, purchasing, and logistics.
• Collaborate with engineering personnel to prepare design modifications enabling manufacturability through existing processes.
• Identify and implement improvements in operations and equipment utilization to enhance efficiency and cost savings.
• Evaluate engineering test results and compile data to establish performance standards.
• Implement and analyze test programs to verify design compliance with functional and performance specifications.
• Ensure project completion within established timelines and budget constraints.
• Work with key organizational leaders and departments to foster cohesive workflow and business outcomes.
• Serve as a plant leadership team member promoting safety, quality, and teamwork.
• Employ a hands-on approach with front-line employees to drive sustainable continuous improvement activities.
• Perform other duties as assigned.

Required Qualifications

• 5 - 10 years of experience in product development engineering or equivalent combination of education and experience.

Preferred Qualifications

• Bachelor's degree in Engineering or Manufacturing Engineering strongly preferred.
• Proven track record in medical device design and development.
• Knowledge of emerging trends and ability to influence best practices in Medical Device development.
• Familiarity with Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Knowledge of ISO 13485 Quality Management System and FDA 21CFR 820 Regulations.
• Strong leadership and project management skills.