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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: https://www.partnersinstaffing.com/find-jobs or https://www.partnersinstaffing.com/manufacturing-engineering Not the right fit

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