Minimum degree and required experience:

• B.S. (or higher) in Electrical Engineering or other Engineering discipline required.
• 5-10 years minimum of progressively more responsible experience related to establishing and maintaining quality system elements as it relates to product development and manufacturing in the medical device industry.
• Five or more years demonstrated experience and expertise in achieving worldwide regulatory requirements relating to medical electrical equipment.
• Working knowledge of regulatory compliance processes involving regulatory bodies/standards such as FDA, Health Canada, and the European Medical Device Directive.

• Working knowledge of standards for medical electrical equipment development such as biocompatibility, sterilization, risk management, and quality management systems including IEC 60601, ISO 10993, ISO 11135, ISO 14971, and ISO 13485.
• Reasoning Ability: Ability to define problems, interpret data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of conceptual and practical problems.
• Technical skills: Ability to propose, coordinate, and direct tests to verify product compliance, performance, quality, and robustness. Remain current on relevant standards to support product compliance testing for both new and existing products. Strong working knowledge of safety testing equipment and techniques for the purpose of safety and environmental compliance testing.
• Strong interpersonal skills: Function as a “team player” and work constructively and cooperatively with all departments in the interests of the business. Effectively communicate with all organizational elements and motivate people in a positive, constructive manner.
• Good organization skills: must be able to manage multiple tasks and prioritize workflow while working independently
• Working knowledge of Microsoft Suite (Word, Excel and PowerPoint) required. Strong Excel skills required including VLOOKUP, Pivot Tables, and statistical analysis.

What We Will Give You

• Access to a diverse, multicultural and caring family-like team
• The challenge of fitting various employee and company organized events (hiking, biking, football (soccer), volleyball, gaming…) into your working day
• A free bike/ski helmet
• Fantastic facilities with showers, bike parking and a direct view of trails up the Wasatch Front
• Medical, vision and dental insurance
• Life and AD&D insurance
• Short and long-term disability insurance
• Flexible vacation/sick leave
• Paid maternity, paternity and adoption leave
• 401(k) with generous matching and immediate vesting
• An opportunity for personal development and a career that will impact other people’s lives in a fundamental way