Senior Product Development Engineer
Full Time. Louisville, CO
Bolder Surgical™ is seeking an experienced Senior Product Development Engineer who has excellent technical judgment, customer focus and proven success in developing new medical device technologies from product concept to full-scale production. In our small company environment, leadership, hands on technical skills, and working well across the organization are necessary to successfully develop products that meet market needs, organizational objectives and project goals. This person will function as an R&D team member and may also lead development projects or phases of projects.
Additionally, this individual should have:
- Strong desire to be part of a very dynamic, growing, and mission driven company
- Demonstrated ability to thrive in a high-paced, rapid changing environment
- Demonstrated Team Player able to work with an experienced JustRight team with confidence and professionalism
- Ability to contribute to multiple, concurrent projects
Excellent writing and communication skills
Working as a member of, or leading, a new product development team responsible for all aspects of product development from concept through manufacturing transfer including functionality, manufacturability and assembly.
- Communicating with customers and understanding needs. Then translating needs into product and manufacturing specifications and, ultimately, working devices.
- Understanding product development challenges and using critical thinking skills and technical judgement to troubleshoot and overcome them.
- Documenting design and development work including engineering analyses, drawings, GD&T, tolerance analysis, FMEA, test plans, protocols, and reports, specifications, failure analyses and design review.
- Maintaining extensive knowledge of component manufacturing processes, prototype and production assembly methods and how to effectively design medical products for them.
- Optimizing design with suppliers and manufacturing for manufacturability and assembly.
- Partnering with our Operations team to prepare for and execute effective pilot production strategy and product transfer to manufacturing.
- Designing and implementing assembly fixturing and test equipment for prototyping, development builds and pilot production.
- Building, testing and evaluating designs for engineering evaluation, Design Verification and Validation and Production Qualification.
- Summarizing Verification and Validation activities for Regulatory Clearance documents.
Assist in, or lead, the following:
- New Product Concept Development
- Communicate with and observe customers and understand needs
- Develop product ideas
- Design, prototype and test concepts against customer needs and manufacturability
- Create Product Definition document for transition to development
- New Product Development
- Develop and document detailed product design
- Build and test prototypes including customer feedback
- Create or oversee creation of all required project documents
- Plan, execute, and document all Verification and Validation activities
- Supply all reports and documentation required for Regulatory submission and Technical File creation
- Support transition to manufacturing ensuring product continues to meet all customer requirements
- Intellectual Property
- File all applicable invention disclosures and work with IP counsel to file applications
- Complete Freedom to Operate analysis with IP Counsel
Bachelor’s degree (Master’s Degree highly preferred) in mechanical Engineering, Biomedical Engineering or related engineering discipline.
- 5-7+ years of significant experience in medical device product development, preferably in a technical leadership role.
- Experience working with vendors to develop precision components, assemblies and the processes to make them.
- Experience prototyping and testing complex mechanical assemblies and/or fixturing.
Work Environment / Physical Demands
Ability to work flexible hours
Travel up to 20%
Typical office environment
Includes work in a biology and engineering lab
May include observation in a surgical operating room
Bolder Surgical™ is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.