Development Engineer

Position Summary

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

Qualifications            

·        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.

Responsibilities

The range of responsibilities includes but not limited to design and development, bench testing, design analysis, design verification testing and validation, design of test equipment, test method development, 3D CAD modeling and documentation, material research, prototype design, manufacturing support and interface with the cross functional team. The incumbent will assist in assuring that product output: (i) meets or exceeds all quality system requirements; (ii) meets productivity standards; and (iii) is efficient with respect to the utilization of ABS resources. Core responsibilities include (but not limited to):

Technical

·       Research, develop, design, and evaluate ABS' medical device implant(s) and delivery system(s)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/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 activities and manufacturing operations.

·       Generates work instructions, test methods, engineering models and drawings/prototype to characterize product and process specifications.

·        Create equipment qualification protocols, product/process specifications, analytical method qualifications, validation strategies/protocols/reports.

Project Management/Leadership/Communication

·        Adhere to the Company's Quality Management System (QMS) as well as 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 and effective organization.

·        Assist in training personnel to processes associated with design and development and manufacturing.

·        Other duties and responsibilities as mutually agreed.

Attributes

·        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).

Physical Demands

Business travel from 0% - 20%. Requires some lifting and moving of up to 40 pounds. Required to frequently stand, walk, sit, and use a computer for extended periods. Specific vision abilities required by this job include, close/distant vision and depth perception. Position also requires use of Personal Protective Equipment, as needed.

Compensation

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