R-D Engineer II

Medtronic • North Haven, CT

1d • $88,800 - $133,200 • Onsite

About The Position

The R&D Engineer II supports the Surgical Operating Unit (OU) Standards Management program by assessing regulatory and industry standards for applicability to Surgical products and ensuring continued product compliance. This role reviews new and revised standards, evaluates existing product data for compliance, and leads or supports investigations to determine remediation strategies where needed. The engineer partners with cross-functional teams including R&D, Quality, Regulatory Affairs, and Product Development to maintain alignment with evolving global regulatory requirements.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field and a minimum of 2 years of relevant experience; OR Master’s degree in Engineering, Life Sciences, or a related technical field with 0-2 years of relevant experience.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

• Prior experience in Medtronic Surgical OU.
• Experience with medical device regulatory standards (for example IEC, ISO, FDA guidance).
• Experience performing gap assessments or standards impact assessments.
• Knowledge of design controls and product development processes in a regulated environment.
• Strong written and verbal communication skills.
• Experience reviewing technical standards, test methods, or regulatory guidance preferred.
• Ability to analyze technical data and assess compliance with regulatory or industry standards.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Review applicable regulatory and industry standards and determine applicability to Surgical OU products.
• Assess product documentation, test reports, and design data to determine compliance with applicable standards.
• Monitor new and revised standards and evaluate potential impact to existing and developing products.
• Lead or support investigations related to standards updates to determine remediation activities required to maintain compliance.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, and Product Development to implement standards-related updates.
• Support standards management processes including documentation, gap assessments, and compliance tracking.
• Provide technical expertise during research and/or product development activities.
• Design, develop, analyze, and troubleshoot engineering solutions related to product compliance and standards implementation.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level