Position Overview
We are seeking a highly experienced Principal R&D Engineer to lead the translation of breakthrough technologies into fully realized, manufacturable products. This role partners closely with Discovery, Clinical, Marketing, and Manufacturing teams to ensure innovations progress effectively through the Product Development Process (PDP) and into production.
The ideal candidate combines deep first-principles engineering expertise with advanced statistical analysis capabilities and demonstrated leadership in complex product development environments.
Key Responsibilities
Technical Leadership & Innovation
- Lead the design, improvement, and optimization of complex experiments and test methods; analyze results and translate findings into actionable product recommendations.
- Apply strong first-principles engineering (stress, strain, material properties, fluid mechanics, etc.) to validate product viability, functionality, and cost targets.
- Develop and validate engineering models, prototypes, drawings, and technical reports to define product and process specifications.
- Identify and resolve highly complex technical challenges involving parts, components, and subsystems.
- Provide expert technical direction on solution strategies and design decisions.
Product Development & Cross-Functional Collaboration
- Partner with Clinical and Marketing teams to define unmet clinical needs, project scope, and operational environments — translating these into robust product performance requirements.
- Lead complex design control activities including requirements specifications, risk documentation, and regulatory-aligned development processes.
- Develop project plans to evaluate emerging technologies and drive measurable project outcomes.
- Represent the organization as a key technical contact for significant contracts and cross-organizational initiatives.
Reliability, Analysis & Validation
- Assess component, subassembly, and full-system reliability using statistical methods such as sensitivity analysis, Monte Carlo simulations, and tolerance stack-ups.
- Validate material selection based on stress/strain conditions, environmental exposure, and biocompatibility requirements.
- Guide manufacturability enhancements and support yield and throughput estimation activities.
Mentorship & Team Leadership
- Oversee R&D support activities and provide direction to engineers and technicians conducting testing and analysis.
- Train and mentor team members in reliability analysis, first-principles design, materials engineering, and requirements traceability.
- Influence change through strong leadership, collaboration, and technical credibility.
Compliance & Operational Excellence
- Ensure adherence to Environmental Health & Safety (EHS), Quality, and clean room medical device manufacturing standards.
- Maintain rigorous documentation practices and uphold company policies and regulatory requirements.
- Manage competing priorities in a fast-paced, highly regulated environment.
Qualifications
Education & Experience (one of the following):
- Bachelor’s degree in Engineering or Scientific field with 8+ years of relevant experience
- Master’s degree with 7+ years of relevant experience
- Ph.D. with 4+ years of relevant experience
Technical Expertise:
- Deep knowledge of engineering principles (mechanics, materials, fluid systems, etc.)
- Advanced statistical analysis capabilities
- Reliability engineering methodologies
- SolidWorks proficiency
- Minitab proficiency
- Strong understanding of manufacturing processes and equipment
Core Competencies:
- Exceptional analytical and critical thinking skills
- Strong written and verbal communication
- Advanced problem-solving capability
- Demonstrated leadership and ability to influence cross-functional stakeholders
- High attention to detail
- Ability to interact effectively across all organizational levels