Senior R & D Engineer

About the Role:

Nextern is seeking a dynamic and experienced Senior R&D Engineer to drive innovation in our product development efforts. In this pivotal role, you will collaborate with cross-functional teams to take projects from ideation through to commercialization, making a significant impact on healthcare solutions.

Your Key Responsibilities:

• Lead the conceptualization, design, and development of new medical devices while adhering to Quality System Requirements.
• Act as the technical lead on multiple projects, managing development teams through various stages of product life cycles.
• Design and assemble prototype devices to assess their technical feasibility and performance.
• Convert user and patient needs into comprehensive design requirements, ensuring they meet verification and validation standards.
• Create robust test methods and develop design test fixtures for accurate evaluation of product specifications.
• Effectively communicate progress and project updates across departments to enhance collaboration.
• Tackle complex technical challenges by identifying and implementing innovative solutions.
• Engage with healthcare professionals to gather insights and ensure design considerations address real-world applications.
• Document protocols and generate reports on engineering studies using proven statistical methods.
• Collaborate with suppliers for component sourcing, fostering strong business relationships.
• Oversee verification and validation activities during regulatory approvals and design transfer phases.
• Contribute to the expansion of our product portfolio through design improvements and line extensions.
• Mentor junior engineers and peers to uplift the technical capabilities within the R&D department.

Qualifications:

• Bachelor’s Degree in Engineering or a related field coupled with 5 years of relevant experience, or 8 years of technical experience in lieu of a degree.
• Strong analytical and problem-solving skills applied to product development.
• Excellent written and verbal communication capabilities for clear interaction with cross-functional teams.
• Proven ability to work independently and manage multiple projects efficiently.
• Strong interpersonal skills, allowing for effective collaboration within a team environment.
• Familiarity with statistical analysis techniques to support decision-making processes.
• Proficiency in software applications including Solidworks, spreadsheets, and databasing tools.
• Hands-on knowledge of lab equipment and practices, such as calipers, micrometers, and tensile testers.
• Understanding of US and international regulatory standards applicable to the medical device industry.

Preferred Skills:

• Experience with materials and processes related to medical device manufacturing, such as extrusion, injection molding, and catheter fabrication.
• Knowledge in project management fundamentals, design controls, and quality systems.
• CAD design expertise, preferably using Solidworks.
• Familiarity with clinical applications and the ability to translate these into detailed product requirements.
• Demonstrated success in guiding products through development to successful market launch.

If you are ready to make a meaningful difference in the medical device industry and thrive on tackling challenges, we invite you to apply for the Senior R&D Engineer position at Nextern!

• The expected salary for this position is between $100,000-$130,000 annually, depending on experience, skills, qualifications.
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.