Senior R&D Engineer

Job Summary

Support product development activities from concept to commercialization

Principal Responsibilities

• Conceptualize, design and develop new devices or elements of new devices with the intent of commercialization per Quality System Requirements
• Participate as a technical lead on multiple cross-functional development teams that manage projects from concept through commercialization.
• Design, assemble, and evaluate prototype devices/assemblies in order to assess technical feasibility of various solutions.
• Support accurate and efficient translation of user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, and test method, and procedures while adhering to design controls best practices.
• Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
• Communicate deliverable status cross-functionally to facilitate the product development process.
• Serve as technical lead for given projects/products, identifying, developing, and implementing solutions to complex problems.
• Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance.)
• Author protocols and reports including engineering studies using basic statistical methods.
• Communicate with outside suppliers for component and equipment sourcing and refinement.
• Assist or own verification and validation activities through regulatory clearance and design transfer, including building finished devices for the purposes of verification/validation.
• Contribute to design/development of product line extensions and product improvements.
• Mentor peers and junior engineers to advance R&D department technical ability and core competencies.

Requirements

• Bachelor's Degree in Engineering or related technical field and 5 years related work experience (or 8 years of related experience without a degree)
• Ability to apply analytical skills and technical principles to problem solving and product development.
• Good written and verbal communication skills
• Performs work with minimal supervision, in a timely manner.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.
• Familiarity with statistical techniques
• Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database and other applicable software programs.
• Working knowledge of common lab equipment (caliper, micrometer, tensile tester, pressure tester, vision measurement system) and knowledge of lab practices and techniques).
• Working knowledge of United States and international standards as applicable to the department.

Preferred Skills

• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required.
• Must possess knowledge, understanding and skills in: generating new product designs/concepts, catheter materials, processes and design plus test methods and metrology; project management, documentation, design control methodology, and a working knowledge of quality systems and medical device regulations.
• CAD design using Solidworks.
• Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
• Experience taking products through the development process to launch.

Benefits

• The expected salary for this position is between $90,000-$120,000 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
• Taco Thursdays!!!

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.