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
The Manager, Mechanical Engineering leads and oversees mechanical engineering activities across all phases of the medical product development lifecycle. This role provides technical leadership, people management, and independent technical review to ensure high-quality, compliant, and efficient execution of client programs. The Manager partners cross‑functionally to deliver innovative medical device solutions while developing and mentoring a high-performing engineering team.
What You Will Do
- Lead mechanical engineering activities through all phases of the medical product development process, from conceptual design through detailed engineering, design verification and validation, and manufacturing transfer
- Provide management, leadership, and technical guidance to mechanical engineers, including workload planning, prioritization, coaching, and professional development
- Act as an independent technical reviewer at key program milestones, including technical, phase, and risk management reviews, advising on corrective actions as needed
- Ensure compliance with applicable medical device regulations and standards, including FDA QSR and ISO requirements
- Organize and deploy mechanical engineering resources effectively to meet program timelines, quality expectations, and business objectives
- Direct and lead internal engineering resources and manage external development partners as required
- Monitor team performance, establish productivity standards, and contribute to performance management processes
- Participate in business development activities, including proposal reviews and client meetings
- May serve as the mechanical engineering lead on assigned product development programs
- Provide input into functional strategy and report on metrics that measure team impact and performance
Required Qualifications
- Bachelor’s degree in Mechanical Engineering or an equivalent combination of education and relevant experience
- 5–8 years of relevant mechanical engineering experience, including 1–2 years in a leadership or people management role
- Working knowledge of the medical product development process
- Working knowledge of FDA QSR and ISO regulations applicable to medical devices
- Strong mechanical product development skills
- Good people management skills, including coaching, mentoring, interviewing, and performance feedback
- Excellent written and verbal communication skills
- Strong attention to detail and the ability to manage multiple projects and priorities
- Ability to communicate complex technical and business concepts to a multidisciplinary audience
- Ability to manage team resources to achieve departmental objectives
- Hybrid working conditions in the Providence, RI site
Preferred Qualifications
- Prior experience in a consulting, CRO, or medical device development environment
- Experience supporting design verification, validation, and manufacturing transfer
- Experience working with external development partners or contractors
- Exposure to business development or client-facing activities
Location
- This is a hybrid role in Providence, RI.
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.