R&D Engineer II (Medical Devices)

TL;DR

R&D Engineer II (Medical Devices): Assessing regulatory and industry standards for Surgical products with an accent on product compliance and remediation strategies. Focus on reviewing new standards, evaluating product data, and collaborating with cross-functional teams to maintain global regulatory alignment.

Location: Onsite in North Haven, Connecticut, USA

Salary: $88,800–$133,200

Company

hirify.global is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Assess regulatory and industry standards for applicability to Surgical OU products.
• Review product documentation, test reports, and design data to ensure compliance.
• Monitor new and revised standards to evaluate potential impact on existing and developing products.
• Lead or support investigations to determine remediation activities required to maintain compliance.
• Collaborate with R&D, Quality, and Regulatory Affairs to implement standards-related updates.
• Design and troubleshoot engineering solutions related to product compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field with 2+ years of experience, or a Master’s degree with 0-2 years of experience.
• Unrestricted U.S. work authorization is required at the time of hire (sponsorship is not available for this level).
• Must be based in or able to work onsite in North Haven, Connecticut (minimum 4 days a week).

Nice to have

• Experience with medical device regulatory standards such as IEC, ISO, and FDA guidance.
• Experience performing gap assessments or standards impact assessments.
• Knowledge of design controls and product development processes in a regulated environment.
• Prior experience within hirify.global Surgical OU.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and tuition assistance/reimbursement.
• Employee Stock Purchase Plan and Employee Assistance Program.
• Global well-being program (Simple Steps).