Product Development Engineer

Job Description

About the Role

Pinnacle Partners is recruiting for a Product Development Engineer on behalf of a client in Indianapolis, Indiana. We are seeking an innovative engineer who enjoys taking products from concept through commercialization while working in a collaborative, hands-on environment. This role offers the opportunity to lead new product development projects, build and test prototypes, collaborate across multiple departments, and help bring innovative medical devices to market.

Key Responsibilities:

• Lead and own new product development projects from concept through commercialization.
• Manage approximately 70% new product development and 30% sustaining engineering initiatives.
• Translate customer, clinician, and product management needs into engineering requirements and product specifications.
• Design and model components using CAD software (SolidWorks preferred).
• Build and evaluate functional prototypes using hands-on fabrication techniques.
• Select materials and components for prototypes and production products.
• Develop verification test methods, protocols, and validation plans to ensure products meet design requirements.
• Conduct product testing, analyze results, and recommend design improvements.
• Create and maintain Design History Files (DHF), engineering drawings, specifications, test reports, and technical documentation.
• Perform product risk analysis and implement mitigation strategies throughout the product development lifecycle.
• Support Design for Manufacturability (DFM) and manufacturing transfer activities.
• Collaborate with Manufacturing, Quality, Product Management, Marketing, Sales, Customer Service, Clinical teams, and international engineering teams.
• Support patent activities by providing engineering drawings and technical documentation.
• Manage prototype and laboratory equipment used for product development and testing.

Requirements:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Design, Design Engineering, or a related engineering discipline.
• Experience leading products through the complete product development lifecycle from concept through production.
• Hands-on prototyping and research & development experience.
• Experience with product verification, validation, product testing, and test method development.
• Strong understanding of Design for Manufacturability (DFM).
• Experience creating engineering documentation, technical reports, and Design History Files (DHF).
• CAD proficiency, preferably with SolidWorks.
• Strong analytical, problem-solving, and communication skills.
• Ability to collaborate effectively with cross-functional teams throughout product development.

Preferred:

• Medical device or other FDA-regulated product development experience.
• Knowledge of ISO 13485 and regulated product development processes.
• Experience with patent support and engineering documentation.
• Exposure to RF welding or sewing technologies.
• Experience supporting new product launches and sustaining engineering projects.

Benefits Overview:

• Competitive salary of approximately $90,000-$105,000
• Medical, dental, and vision insurance.
• Company-paid life insurance and short-term disability.
• Long-term disability coverage.
• 401(k) with employer match.
• Health Savings Account (HSA) employer contribution.
• Wellness reimbursement up to $250 annually.
• Childcare reimbursement up to $250 annually.
• Paid vacation and merit increase opportunities.
• Opportunity to work on innovative medical devices while owning projects from concept through commercialization.
• Collaborative engineering environment with hands-on prototype development and long-term growth opportunities.

Explore More Engineering Opportunities

This role falls within our Engineering/Manufacturing division, where we specialize in placing professionals in areas such as:

• Mechanical/Electrical Engineer
• Manufacturing/Process Engineer
• Controls Engineer
• Designer/Drafter
• Operations (Plant Engineering)

Explore additional Engineering roles and learn more about how we support Engineering professionals:

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• Human Resources
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