Careers

Reporting to the Engineering management, the Development Engineer will have responsibility for key aspects of ABS’s research & development (R&D) and product manufacturing processes.

• Bachelor’s degree in biomedical engineering, mechanical engineering, or related technical field preferred.
• Exposure to the medical device industry including medical device design and new product development.
• Basic knowledge of design controls.
• 0–2 years of relevant experience.

Technical

• Research, develop, design, and evaluate ABS’ medical device implant(s) and delivery system(s) with effective application of applicable design controls through all phases of development — concept to commercialization — while maintaining detailed documentation through all phases of R&D.
• Design and build prototypes and conduct testing to characterize, verify, and validate safety and essential performance. Analyze data using statistical techniques as applicable, and communicate results.
• Create and update design control documents, write protocols and reports.
• Update and maintain Design History Files (DHFs).
• Assess potential new suppliers for technical, quality and manufacturing capabilities; review and coordinate vendor activities to support product development and manufacturing operations.
• Generate work instructions, test methods, engineering models, and drawings/prototypes to characterize product and process specifications.
• Create equipment qualification protocols, product/process specifications, analytical method qualifications, validation strategies, protocols, and reports.

Project Management / Leadership / Communication

• Adhere to the Company’s Quality Management System (QMS) and applicable domestic and global quality system regulations, standards, and procedures.
• Support the technical and functional integration of projects through collaboration with suppliers and internal/external cross-functional teams.
• Assist in training personnel on processes associated with design, development, and manufacturing.

• Innovative, creative, team player.
• Strong written and verbal communication skills.
• Ability to work in a rapidly changing and evolving environment.
• Strong knowledge of analytical tools and CAD software (e.g., SolidWorks, Minitab).
• Working knowledge of applicable regulations and standards (FDA, ISO).

Business travel 0–20%. Requires some lifting and moving of up to 40 pounds. Frequent standing, walking, sitting, and computer use for extended periods. Close/distant vision and depth perception required. Position may require use of Personal Protective Equipment.

Salary range of $80,000–$120,000 USD per year, plus benefits, potential for performance-based bonus, and equity participation.