Visionary Leader
9 hours ago
We are seeking an exceptional individual to join our team as a Lead Technical Specialist.
This role will involve technical leadership in the development of new system solutions and guiding a team of engineers in the design, characterization, and verification testing of medical devices.
The successful candidate will apply their expertise in product development, communication, problem-solving, and knowledge of best practices to lead the team through complex issues related to design, operations support, and product release.
- Develops and implements all aspects of system design, development, and validation of medical device systems and products.
- Maintains knowledge of product development, clinical (good to have), and regulatory requirements.
- Collaborates with other teams to investigate and evaluate existing technologies.
- Leads the team in developing new concepts from initial design to market release and sustaining existing products.
- Ensures documentation maintenance throughout all phases of development.
- Coordinates activities across product teams to ensure timely delivery of systems for design characterization, verification, and validation testing.
- Selects, develops, and evaluates personnel to ensure efficient operation of the function.
- Demonstrates strong technical leadership skills to guide and mentor engineers involved in the system SI&T process.
- Drives continuous improvement initiatives to enhance efficiency and effectiveness of systems verification and validation processes.
- Communicates effectively with internal teams and external stakeholders, providing technical insights and updates on systems verification and validation progress.
To be successful in this role, you will need to combine your experience with training and mentorship to move your career forward. If you want a challenging, energizing, rewarding career that changes lives, consider joining us.
Requirements:
- Bachelor's or master's degree required with Minimum of 15+ years of relevant experience.
- Experience managing a cross-functional engineering technical team size of 20 or more.
- Ability to provide a blend of people management and technical savviness.
- Deep understanding of embedded and application SW development processes (Agile, waterfall methodology) and establishing metrics & recommended processes for the team.
- Experience with validation of test methods, hard and software, test fixtures.
Nice to Have:
- Knowledge of how to manage teams in a large organization, especially at multiple locations and remotely.
- Strong communication skills: Ability to coordinate people and teams around unstructured challenges and moving project priorities.
- Knowledge of product development workflow.
- Knowledge of medical device development process: 60601, 13485, 62304.
- Able to inspire a team and show vision.
- Passion for learning new things.
Key Responsibilities:
- Reports to the Sr. Engineering Manager.
- Accountable to Project Manager(s) for project-related responsibilities.
- Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules.
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