Sr Mechanical Engineer

Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients' innovations to market. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

About This Role

We are seeking a seasoned Senior Mechanical Engineer to lead the design and development of complex electro-mechanical medical devices. This role is integral to our product development lifecycle, from concept through validation and manufacturing transfer. The ideal candidate will bring deep technical expertise, leadership capabilities, and a passion for innovation in the medical device space.

What You Will Do

• May lead the design and development of complex electro-mechanical medical devices and equipment.
• Generate expert-level 3D and 2D CAD data.
• Develop and integrate high-functioning design prototypes with minimal guidance.
• Execute prototype testing plans and ensure compliance with safety standards.
• Provide leadership, training, and mentorship to junior engineers.
• May direct internal resources and manage external development partners.
• May function as the mechanical engineering lead on product development programs.
• Ensure compliance with FDA, QSR, and ISO regulations.
• Participate in business development activities, including proposal review and client engagement.
• Translate Client needs, user insights, and clinical requirements into innovative, feasible, and complaint product concepts.
• Drive system-level design and integration across mechanical, electrical, software, and human factors disciplines.
• Develop, prototype, and iterate design solutions quickly, leveraging hands-on experimentation and engineering analysis.

Required Qualifications

• Bachelor's degree in Mechanical Engineering.
• 3-6 years of relevant work experience in medical device development.
• Thorough knowledge of product development and strong understanding of the medical device industry.
• Excellent written and oral communication skills.
• Strong analytical and conceptual skills with the ability to build functional prototypes.
• Ability to solve moderate to complex technical problems.
• Ability to solve problems of diverse scope.
• Exercises judgment in selecting methods and techniques for obtaining solutions.
• Strong ability to manage multiple tasks and projects effectively.
• Familiarity with FDA, QSR, and ISO standards.
• Ability to work independently with minimal guidance.

Preferred Qualifications

• Experience leading cross-functional teams and managing external partners.
• Prior involvement in business development or input to proposals.
• Advanced CAD proficiency and rapid prototyping experience.
• Participation in audits and inspections for medical device projects.

Location

• This is a hybrid position based in Providence, RI OR Minneapolis, MN

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.