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:
This role falls within our Engineering/Manufacturing division, where we specialize in placing professionals in areas such as:
or
Not the right fit?
We're hiring across multiple divisions including:
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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.
- 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.
- 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.
- 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.
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)
or
Not the right fit?
We're hiring across multiple divisions including:
- Human Resources
- Administrative & Customer Service
- Information Technology
- Accounting & Finance
#ENG123