SUMMARY: The Principal R&D Engineer will be responsible for coordinating and executing new product development according to customer specifications. They will also develop early concept prototypes and support the business development cycle for Nextern. The engineer will manage the complete device project, establish product requirements, participate in risk management activities, and ensure that the product meets the requirements. Collaboration with Design Assurance, Process Development, Supply Chain, and Operations is essential in executing these responsibilities.

DUTIES AND RESPONSIBILITIES:

• Coordinate new product development with customers and internal project teams.

• Review customer requirements and evaluate if they align with Nextern's core competency and vision.

• Build prototypes, perform testing, and determine concept feasibility.

• Translate high-level customer requirements into manufacturable product requirements and establish a suitable design.

• Create risk management documentation in collaboration with Design Assurance.

• Work with CAD designers to complete component and assembly drawings and establish BOM structure.

• Collaborate with supply chain to obtain BOM pricing and order raw materials/components.

• Develop component qualification documentation and procedures for pilot builds.

• Generate documentation to support pilot builds and facilitate the process.

• Assist in developing testing plans, executing tests, and participating in technical design reviews.

• Evaluate process repeatability and stability through equipment qualification and process validation.

• Transfer development projects to appropriate manufacturing locations in collaboration with Process Development.

• Aid in proposal and cost model development for management review.

• Provide support in resolving product complaints and safety issues.

• Ensure compliance with internal QSP requirements, company goals and objectives, and FDA/QSR regulations.

• Perform other assigned duties by management.

Requirements

• Bachelor’s degree in engineering with 10 - 15 years of relevant experience and/or training, or equivalent combination of education and experience.

• Dedication to excellence and high standards.

• Exceptional written and verbal communication skills.

• Strong organizational, problem-solving, and analytical abilities.

• Effective management of priorities and workflow.

• Adaptability, flexibility, and eagerness to work within dynamic priorities.

• Paying close attention to detail.

• Demonstrated aptitude for planning and organizing projects.

• Proven ability to handle multiple projects and meet deadlines.

• Sound judgement with the ability to make timely decisions.

• Creative, flexible, and innovative team player.

• Proficiency in data collection, data analysis, evaluation, and scientific methodology.

• Familiarity and comprehension of the fundamental principles, theories, concepts, and practices in the relevant engineering/technical specialization.

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance for employees

• Employer paid dental insurance

• Employer HSA contribution

• 401k plan with a company match

• 9 paid holidays (including your birthday!) + PTO and Personal days

• Gym membership subsidy

• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Salary Range for This Position: $130,000 - $180,000.

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.