Product Development Engineer

Top Shelf Manufacturing specializes in designing and manufacturing orthopedic and sports medicine medical devices and a growing offering of active consumer products. The company markets product to physician’s in orthopedics and sports medicine, athletic trainers, physical therapist, and other medical device distributors and companies.

We have an immediate opportunity to join our growing company. We are currently seeking a full-time (M-F 8:00 AM-5:00 PM) Product Development Engineer for our Tracy, CA office.

Job Summary:

The Product Development Engineer leads the end-to-end development of new and existing products from concept through production, ensuring products are innovative, manufacturable, cost-effective, and aligned with business objectives. This role oversees product development initiatives while partnering closely with manufacturing, operations, quality, and cross-functional teams to optimize design, production readiness, and continuous improvement efforts.

Duties/Responsibilities:

· Lead product development strategy and execution from concept, prototyping, testing, validation, and launch through full-scale production.

· Manage cross-functional collaboration between design, operations, manufacturing, quality, and supply chain teams to ensure successful product commercialization.

· Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) principles throughout development processes.

· Oversee manufacturing process development and production readiness for new product introductions.

· Evaluate and improve manufacturing methods, workflows, tooling, and production efficiency.

· Establish timelines, budgets, milestones, and deliverables for development and production projects.

· Lead continuous improvement initiatives to enhance product quality, reduce costs, and improve operational efficiency.

· Support troubleshooting and resolution of technical, manufacturing, and production-related issues.

· Develop and maintain documentation, standards, and best practices for product and manufacturing development processes.

· Collaborate with vendors, suppliers, and external partners on component development, sourcing, and manufacturability.

· Mentor and develop technical staff while fostering a culture of innovation, accountability, and operational excellence.

· Ensure compliance with industry standards, safety regulations, and quality requirements.

· Assist in the development of products for sale by Top Shelf

· Produce all drawings and documentation required to produce prototype and production products

· Produce a comprehensive bill of materials (BOM) per new product

· Update or produce comprehensive bill of materials for all current Top Shelf products

· Look for new materials to reduce costs, improve quality and drive value.

· Analyze currently produced products for cost reduction opportunities with manufacturing, purchasing and marketing.

· Maintain status of all current projects regardless of status in product development continuum

· Assist marketing, customer service, and purchasing in providing needed information for a product release.

· Provide detailed material specifications to vendors/purchasing for new product needs

· Provide support and feedback to manufacturing and purchasing to ensure materials received meet required specification

· Special orders- provide needed information to manufacturing to produce a special product

· Maintain document control for all currently produced products to ensure compliance as an FDA registered medical device facility/company

· Assist as needed in the day-to-day operational needs of Top Shelf

· Perform other duties as needed.

Required Skills/Abilities:

Technical degree in design and 10+ years’ experience in product design.

· Ability to manage multiple tasks

· Must have a sense of urgency and be deadline oriented.

· Must have strong analytical skills

· Must have strong interpersonal skills and communication skills.

· Demonstrates attention to detail /organizational skills.

· Excellent written and verbal communications.

· Ability to work independently within a team environment.

· CAD and Solidworks proficiency

Education and Experience:

· Bachelor’s degree in engineering, Design, Business or a related field is preferred.

· At least one year of Product Design management experience is preferred.

Physical Requirements:

· Prolonged periods of sitting at a desk and working on a computer.

· Must be able to access and navigate each department at the organization’s facilities.

Compensation Range: $90,000 - $110,000 annually

Additional Benefits for Full-Time Employees (3 to 4 weeks of Paid Time Off)
Holidays: 10 paid holidays per year
Vacation Benefit: At completion of 3-month introductory period, vacation accrual up to a max of 40 hours in the first 23 months, at 24 months, accrual up to a max of 80 hours with a rollover balance.
Sick Benefit: Sick accrual begins upon date of hire up to a max accrual of 80 hours annually with a max usage of 48 hours annually with a rollover balance.