Specific Responsibilities:

• Be the verification and validation lead assisting the product development group in developing products to ensure constantly improved instrumentation and cutting-edge technology.
• Write protocols, conduct testing, and write test reports (e.g., performance, simulated use).
• As needed, source appropriate vendors to conduct testing and oversee testing.
• Support the Company Quality System.

General Responsibilities:

• Conduct design verification and validation testing for product development activities.
• Support all technical aspects of the product and instruments.
• Support regulatory requirements.
• Support design control process.
• Support sustaining engineering activities with root cause and engineering analysis.
• Lead engineering change process.
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing.  The employee has the responsibility to report any instances to their direct supervisor or above.
• The Test Engineer must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Qualifications:

• Currently or recently served as test engineer for a high-growth, medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 3 years.  Experience in orthopedics is highly desired, spine experience also a plus.
• Currently or recently performed testing to established standards (i.e. ISO, ASTM).
• Exceptional organization/planning skills (e.g., scheduling) and display initiative and perseverance in meeting deadlines.
• Good technical writing skills with attention to detail.
• Have a demonstrated ability to communicate effectively and work well with co-workers, surgeons, clinicians, and distributor reps.
• Have a working cross-disciplinary understanding of a medical device business emphasizing on engineering, manufacturing, operations, R&D, product marketing, clinical and regulatory, and quality assurance.
• Be known as a person who has high integrity, sound character, a tremendous work ethic and the passion to succeed.
• Currently or recently designed and fabricated mechanical test fixtures to perform mechanical testing using machining (e.g., mill, lathe) or 3D printing.
• A passion for supporting an emerging company and sustaining high growth through engineering support.

Educational Requirements:

• BS in an engineering discipline (Mechanical engineering preferred)