Senior R&D Engineer - Cardiovascular Surgery (Medical Devices)

Location: Santa Ana, California, United States of America; onsite four days per week with less than 10% travel.

Salary: $105,600.00–$158,400.00 annually; eligible for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices intended to alleviate pain, restore health, and extend life.

What you will do

• Maintain the design integrity, reliability, and continuity of commercially available cardiovascular surgical products within Design Control requirements.
• Apply advanced engineering principles and critical thinking to solve complex technical problems related to aortic disease treatment.
• Investigate product design and reliability issues, determine root causes, and implement solutions with R&D, manufacturing, quality, and other cross-functional partners.
• Review and approve post-market change orders, design and process qualifications, and verification and validation documentation.
• Develop technical solutions, conduct testing, evaluate results using statistical analysis, and prepare test reports.
• Oversee process development objectives with internal and external manufacturing partners and provide technical input for regulatory submissions.

Requirements

• Bachelor’s degree in science, technology, engineering, or mathematics plus at least 4 years of technical work experience, or a Master’s degree plus at least 2 years of technical work experience.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for this Senior-level role.
• Ability to work onsite in Santa Ana, California four days per week and travel less than 10%.

Nice to have

• High-level proficiency in technical principles, theories, and design concepts for medical device design.
• Experience with failure analysis and statistical techniques.
• Experience with Nitinol materials and stent processing.
• Experience with textile and suture development and testing.
• Experience with design verification and validation.
• Experience with design and process qualification.
• Ability to provide technical leadership while building a collaborative work environment.

Culture & Benefits

• In-person collaboration and cross-functional teamwork within an inclusive workplace.
• Health, dental, and vision insurance; health savings and flexible spending accounts; life insurance; and long-term disability coverage for eligible regular employees.
• Tuition assistance or reimbursement, dependent daycare spending account, and a global well-being program.
• Incentive plans, 401(k) with employer contribution and match, paid time off, paid holidays, employee stock purchase plan, and employee assistance program.