Product Development Engineer

13 Willow Street, Rutland, VT 05701 Tel: (802) 821-1002

Product Development Engineer

The Role

HD Medical is recruiting a Product Development Engineer (PDE) to realize the CEO’s vision for the Company’s product line. The PDE will be responsible for technical aspects of Product Development, maintenance of the
Company’s Quality Management System, Medical Device development including Design Control activities and oversight, product integration with Manufacturing and Commercialization systems including training material development. In the early stages of HD Medical’s growth, the PDE will be ready to take on less specialized tasks in addition to more advanced responsibilities. Additional responsibilities may be ascribed. The PDE must successfully complete and maintain Quality training commensurate with the role. The PDE is responsible for the following, with activities subject to CEO review and approval:

• Foster team culture of collaboration, camaraderie, tenacity, engagement, ownership, accountability, and purpose
• Execute technical development of new products and existing product improvements from concept to commercialization using prototyping and design tools, testing, design for manufacturing, development of work instructions, and transfer to production
• Lead development plan management and technical efforts for new and existing products, manage communication platform for progress tracking on projects and initiatives related to Product Development and lifecycle management
• Explore and prototype new product concepts and ideas to grow the HDmedical platforms; Collaborate with CEO on technology and product roadmaps, priorities, and timelines
• Develop and lead subject matter expertise in product usability, user experience, and human/device interface;

Lead translation of product attributes and functions to IFU and training programs; Act as SME in audits

• Maintain currency of designs and design documentation, including CAD, product requirements and specifications
• Ownership and management of Design History File, Design Controls, Design Change Management, Design reviews, and product releases to Device Master Record
• Lead development of manufacturing processes for new products and product changes; Oversee and participate in pilot manufacturing
• Manage technical relationships with suppliers with respect to requirements, specifications, and cost; Lead new supplier approval efforts
• Lead continuous improvement developments for product, operational and cost inefficiencies, and usability;

Present justification to CEO for acting on such opportunities

• Manage external service providers and vendors with the goal of identifying the most cost-effective party that meets requirements
• Incorporate research and clinical data into Product Development initiatives and activities
• Execute and manage regulatory compliance system in preparation for FDA, ISO, and other regulatory body audits; Facilitate internal reviews and audits
• Assist and support manufacturing and operations as needed

13 Willow Street, Rutland, VT 05701 Tel: (802) 821-1002

Education, Experience and Skills

Minimum BS in Engineering or similar technical field. The ideal candidate will have experience with design controls (“house of quality,” stage/gate processes, etc.), understanding of multidisciplinary systems (mechanical, electronics, and software), and experience with hands-on fabrication with tools and jigs. Experience with MS
Office, SolidWorks, ClickUp or other project management applications required. Candidate should be proficient in technical writing and working within spreadsheets.

Compensation and Benefits

• This is a full time position
• Salary is $65,000 - $90,000/year depending on experience
• Health, Dental, and 401k

Healthy Design Ltd. Co. dba HDmedcial is an Equal Opportunity Employer (EOE)

Job Type: Full-time

Pay: $65,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• No nights
• No weekends

Ability to Relocate:

• Rutland, VT 05701: Relocate before starting work (Required)

Work Location: In person