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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in device development design controls, regulatory compliance, and risk management, with a strong focus on collaboration and communication across cross-functional teams. Proven ability to lead projects, manage multiple priorities, and enhance device design control processes.
Highest-signal resume keywords
Device Development Design ControlsRegulatory ComplianceAnalytical Method DevelopmentGeometric Dimensioning And Tolerancing (GD&T)ISO 13485 Medical Devices
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical DevelopmentQuality ManagementStatistical AnalysisTechnical WritingMechanical DesignMechanical TestingMethod ValidationPrototypingData InterpretationRisk Assessment Tools
Soft Skills
Excellent CommunicationLeadershipProblem-SolvingAdaptabilityCollaboration
Industry Keywords
Device Systems OperationsManufacturing ProcessesProduct DevelopmentCross-Functional CollaborationPost-Market Surveillance
About the role
Key responsibilities & impact- Lead and contribute device development design controls for assigned projects
- Prepare materials for program presentations for management review and regulatory submissions
- Lead implementation and ensure effective execution of device development strategy and design controls
- Adhere to management-approved strategic plans and corporate policies
- Communicate clearly with cross-functional stakeholders, including external suppliers
- Proactively resolve project obstacles and challenges
- Communicate device development strategy and design controls approach within Device Development and with external suppliers
- Understand and apply regulatory and compliance requirements related to design controls and risk management
- Contribute to development, implementation, and continuous enhancement of device design control processes, procedures, and tools
- Participate in strategic development of the Device Design Control function and contribute to team goals and initiatives
- Collaborate with subject-matter experts across cross-functional combination product development teams throughout the product lifecycle, from concept through launch and post-market surveillance
- Oversee device design control activities to support high-quality products and efficient manufacturing processes
Requirements
What you’ll need- B.S. or master's degree in Engineering, Science, or a related field plus 6 years of related experience
- Minimum of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area
- Strong knowledge of regulatory requirements and industry standards related to device systems
- Strong analytical and statistical skills with experience in data interpretation and risk assessment tools
- Excellent communication, leadership, and problem-solving skills
- Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively
- Experience with analytical method development
- Experience working with external partners
- Knowledge of Geometric Dimensioning and Tolerancing (GD&T)
- Knowledge of ISO 13485 Medical Devices
- Knowledge of manufacturing processes
- Mechanical design experience
- Mechanical testing experience
- Method validation experience
- Product development experience
- Prototyping experience
- Statistical analysis
- Technical writing
- US and Puerto Rico residents only
- No visa sponsorship
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Domestic relocation
- Hybrid work arrangement