Senior Compliance Engineer

Description

The company develops medical technology, and this role sits within its compliance and product safety work on the EVR product line, including the Monadnock program and other product development efforts.

The team is a global group of more than 72,000 people across more than 70 countries, working on medical technology that supports clinical decisions and treatment.

The role suits an experienced professional ready to take the next step in their career, and the company offers resources and flexibility for growth.

Responsibilities

• Lead compliance engineering and product safety strategy for EVR on the Monadnock program and other development work.
• Identify the standards that apply to the system and interpret their individual clauses to set clear, system-specific product safety and compliance requirements for design teams.
• Work with mechanical, electrical, consumables and software design engineers from requirements and early design through design review to compliance verification.
• Plan, coordinate and manage compliance testing with external labs such as those for EMC, electrical safety and other product safety testing, and own those lab relationships.
• Take part in design reviews from a compliance standpoint to confirm the design meets compliance requirements.
• Lead compliance verification planning and execution, and write or co-write test plans, protocols, methods and reports.
• Support product safety risk management and make sure compliance findings lead to the right requirement and risk updates.
• Track compliance status across the program and push findings to timely resolution.
• Keep compliance and product safety documentation current in EVR's quality management system.
• Communicate clearly and often with cross-functional stakeholders, and mentor design engineers on compliance and standards.

Requirements

• Solid hands-on experience in medical device compliance testing and engineering.
• Strong working knowledge of standards for complex active medical devices, including IEC 60601-1 with applicable collateral and particular standards, IEC 60601-1-2 (EMC), ISO 14971, ISO 13485, FDA 21CFR 820 and IEC 62304, plus ISO 10993 and applicable sterilization standards for sterile single-use consumables.
• Demonstrated experience working with external compliance and test labs, such as TÜV or equivalent, to test medical devices.
• Experience interpreting standards and turning clauses into system-specific design and verification requirements.
• Experience with design reviews and design control procedures.
• Strong documentation and communication skills.
• At least 8 years of medical device compliance and product safety engineering experience.
• A bachelor's degree in electrical, mechanical, biomedical or systems engineering, or a closely related field.
• Willingness to travel up to 20%.

Conditions

The base pay range is $118,300 to $162,668. Starting pay within this range depends on factors such as geography or market, skills, education, experience and other qualifications.

Commission eligibility, if applicable, follows the company's plan and is based on individual and/or company performance.

Equal opportunity applies, and the company provides reasonable accommodations for persons with disabilities.

The role requires the ability to work with controlled technology under US export control law, in line with the company's compliance with EAR, ITAR and OFAC rules.

Applicants should submit their CV through the company's talent community profile rather than by email.

Benefits

• Medical, dental and vision insurance, subject to eligibility.
• 401(k) retirement plan.
• Life insurance, plus long-term and short-term disability insurance.
• Paid parking or public transportation.
• Paid time off and paid sick and safe time.