The Senior Product Development Engineer will support all phases of medical device development projects in Boyd's Design Division as part of a highly collaborative team in a fast-paced environment. This hands-on role is centered on mechanical design and CAD, taking ownership of 3D modeling, detailed drawings, and design iterations to expand the capacity of the engineering team and keep programs on schedule. In addition to core CAD responsibilities, the Senior Product Development Engineer contributes across the full development cycle by helping design, prototype, and test devices, and by creating and maintaining the design documentation required in an FDA regulated environment. The Senior Product Development Engineer works closely with senior engineers, project leads, and Quality to translate client requirements into robust, manufacturable designs. Core Competencies & Behavioral anchors

• Consistent execution and self-mastery of the Company's core competencies and behavioral anchors.
• Understanding of the design and engineering services industry and the medical device market.
• Analysis / Reasoning
• Decision making and judgement
• Attention to detail
• Results focused and initiative
• Development and continual learning
• Strong oral and written communication skills, including clear and accurate technical documentation.
• Teamwork and a willingness to support colleagues across design, testing, and documentation tasks.

Essential Duties and Responsibilities Mechanical Design & CAD Creates and maintains 3D solid models, assemblies, and detailed 2D drawings for medical device components and systems using SolidWorks. Takes ownership of the CAD workload on assigned projects, supporting senior engineering staff and enabling the team to meet program timelines. Develops design concepts and iterates designs based on test results, design reviews, and client feedback. Applies GD&T and tolerance analysis to ensure designs are functional, manufacturable, and inspectable. Applies design for manufacturability (DFM) and design for assembly principles to molded, machined, and fabricated components. Maintains CAD data, part numbers, and revision control in accordance with company procedures. Prototyping & Testing Builds, assembles, and modifies prototypes, test fixtures, and tooling. Assists in writing test protocols, executes testing, and documents results in final reports. Conducts feasibility studies and engineering evaluations to determine the ability of designs to function as intended. Analyzes test data and recommends design improvements. Supports design verification activities for products under development. Documentation & Design Controls Creates and maintains Design Control documentation throughout all phases of development, including design inputs, specifications, drawings, and Design History File records. Prepares bills of materials, engineering change orders, and assembly instructions. Supports risk analysis activities, including FMEA, for products under development. Prepares documentation packages to support design transfer to manufacturing, including transfer into Build by Boyd operations. Collaboration & Other Duties Participates in design reviews and project meetings with the internal team and clients, as needed. Coordinates with outside suppliers, machine shops, and vendors to obtain prototype parts and materials needed to meet scheduled timelines. Collaborates with Quality to ensure designs meet internal quality standards and external regulatory requirements. Positively represents the organization's culture, values, and reputation at all times with staff, customers, suppliers, and partners. Other related duties as directed by management. Experience, Education, CERTIFICATIONS, OR Other Requirements B.S. in Mechanical Engineering or Biomedical Engineering is required; M.S. a plus. 5+ years of mechanical design and product development experience. Advanced proficiency in SolidWorks, including part, assembly, and drawing creation; CSWA or CSWP certification a plus. Working knowledge of GD&T and tolerance analysis. Hands-on experience with prototyping, fabrication, and mechanical testing. Knowledge of the product development process in an FDA regulated environment, including design controls and ISO 13485, desired. Strong technical writing and documentation skills. Proficiency in MS Office. Must be able to complete a post-offer, pre-employment criminal background check and drug screen.

Pay:

$110,000.00 - $140,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person