About Rev1 Engineering
At Rev1 Engineering, we bring transformative medical technologies to life. As a full-service product development partner to medical device companies, we deliver innovation at speed—from concept to commercialization—while maintaining the highest standards of quality and compliance.
We are seeking a Senior to Principal level Engineer / Project Leader to lead the design and development of complex Class I, II, and III medical devices in a fast-paced, client-facing environment. This role combines technical leadership, project execution, and strategic influence—ideal for an experienced engineer ready to help shape the future of medical technology.
Key Responsibilities
Technical Leadership & Project Execution
- Lead cross-functional teams in the design, development, and commercialization of complex Class I/II/III medical devices.
- Serve as the lead contact for clients; build trust through clear communication and technical excellence.
- Define and execute all phases of the Product Development Process (PDP) — from concept through production transfer — including feasibility, design verification/validation, and risk management.
- Independently develop and manage projects, including timelines, budgets, and scope.
- Create and review engineering documentation: design inputs/outputs, risk analysis (dFMEA/pFMEA), verification and validation protocols, and test reports.
- Oversee and perform advanced design reviews, test method development, root cause analysis, and verification and validation activities.
- Build, maintain, and expand long-term client relationships through consistent delivery of high-value engineering solutions and project management.
- Apply advanced data analysis, DOE, statistical tools (e.g., k-factors, Ppk, MSA, gage R&R) to evaluate design performance and optimize outcomes.
- Solve complex, open-ended engineering problems using structured logic and sound critical thinking.
- Prioritize and manage multiple project tasks autonomously in fast-paced environments.
Regulatory & Quality Systems
- Operate within an ISO 13485-compliant quality system and ensure all development activities support FDA and CE Mark regulatory filings.
- Support creation and maintenance of Design History Files (DHFs) and regulatory documentation.
- Apply risk-based design approaches and conduct statistical analysis to support design decisions and process validations (IQ/OQ/PQ).
Strategic & Organizational Leadership
- Mentor junior engineers and technicians; contribute to team education, development, and culture.
- Provide strategic input for quoting and planning new projects; contribute to client proposals and internal process development.
- Contribute to internal initiatives including process improvements, best practices, and continuous education efforts across the team.
- Lead by example as a cultural and technical leader, fostering a collaborative and high-performance team environment.
Required Qualifications
- BS in Engineering (Mechanical preferred)
- 7+ years of hands-on medical device development experience
- Deep expertise in the medical device Product Development Process (PDP)
- Experience working within ISO 13485 quality systems and familiarity with FDA/CE regulatory frameworks
- Basic to intermediate knowledge of applied statistics for engineering (Ppk, DOE, MSA, k-factor, etc.)
- Proven ability to lead technical teams and manage multidisciplinary projects
- Ability to operate with minimal supervision and effectively prioritize tasks under changing conditions
- High customer orientation and ability to manage both technical and interpersonal challenges in a client-facing role.
- Excellent communicator utilizing multiple forms of communication (in-person, email, text, IM, chat, et.)
- Experience with managing project budgets
Preferred Qualifications
- Subject Matter Expertise in at least one area:
- Catheter systems, electro-mechanical assemblies, FEA, design for manufacturing, preclinical research, test method development, etc.
- Proficiency in SolidWorks CAD software
- Six Sigma Green or Black Belt certification
- Experience developing a diverse portfolio of medical devices
- Proficiency in project scheduling tools (MS Project, Fusion (aka ProChain), etc.)
- Familiarity with design of experiments, critical thinking, and structured decision-making in ambiguous or novel technical scenarios
Working Conditions & Physical Requirements
- Standard office and lab environment; occasional cleanroom involvement
- Prolonged periods at a desk/computer; occasional lifting up to 15 lbs.
- Ability to travel for client meetings or vendor visits, as needed
Why Rev1 Engineering?
- Join a high-performing team solving cutting-edge medical design challenges
- Lead the development of products that directly improve patient outcomes
- Take part in a culture of technical rigor, collaboration, and continuous improvement
- Competitive salary, full benefits package, and room to grow into strategic leadership
Rev1 Engineering is an Equal Opportunity Employer committed to diversity, equity, and inclusion in the workplace.
Job Type: Full-time
Base Pay: From $100,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
Application Question(s):
- Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?
Work Location: In person
