Follow your passion for product integration to Nextern. We are looking for talented integrators who are knowledgeable in the medical device industry, and looking to make positive disruption towards innovation. Our growing team of diverse engineers, industry leaders, scientists, and forward thinkers is looking for our next collaborator. Could it be you? Global opportunity, impactful work, and great benefits await. Apply today!
This position is primarily responsible for coordinating and executing new product development according to customer specifications, developing hand-on product solutions, and supporting the business development cycle for Nextern. The R&D Engineer will aid in managing a complete device project from the initial concept through Nextern’s detailed phase gate development, seeing it through to manufacturing and commercialization. Responsibilities will also include overseeing the release of specifications, determination of best manufacturing methods, ensuring the product meets specifications, and executing the documentation associated with these activities. The R&D Engineer will work closely with the supplier management, quality, and operations teams to execute these responsibilities.
Previous medical device experience, as well as a willingness to work globally and familiarity conducting international business in Asia is a plus!
Duties & Responsibilities
- Coordinates new product development with customers and internal project teams.
- Review high level design requirements to evaluate whether they are within Nextern core competency and vision.
- Review design and determine required Bill of Materials.
- Take high-level product requirements and translate into a design(s) that is manufacturable and meets or exceeds the requirements.
- Work with CAD designers to complete drawings of components and assemblies.
- Work with supply chain to obtain BOM pricing (from internal and external vendors).
- Assist with development of proposals and costs models for review by management.
- Generate required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Assist in component and device testing protocols, execution of the testing, and writing of test reports.
- Assist in development of plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Work with quality, supply chain and PD to ensure compliance with QSR and internal protocols.
- Provides support in the resolution of product complaints and/or safety issues.
- Works with various departments to facilitate pilot production of new products.
- Support company goals and objectives, policies and procedures, Good
- Manufacturing Practices, and FDA/QSR regulations.
- Transfer as required engineering project from engineering into manufacturing.
- Performs other related duties as assigned by management.
SUPERVISORY RESPONSIBILITIES
- Although this job has no direct reports, the R&D Engineer is expected to provide direction to technicians and operators to complete builds and execute testing.
Qualifications
- Bachelor’s Degree in Engineering and three years of related experience and/or training, or equivalent combination of education and experience.
- Commitment to excellence and high standards.
- Excellent written and oral communication skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
- Acute attention to detail.
- Demonstrated ability to plan and organize projects.
- Proven ability to handle multiple projects and meet deadlines.
- Good judgement with the ability to make timely and sound decisions.
- Creative, flexible, and innovative team player.
- Working knowledge of data collection, data analysis, evaluation, and scientific method.
- Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
Compentencies
- Diversity – Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
- Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
- Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
- Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments
- Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
- Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed
Physical Demands and Work Environment
- Occasionally required to stand.
- Frequently required to walk.
- Frequently required to sit.
- Frequently required to utilize hand and finger dexterity.
- Occasionally required to climb, balance, bend, stoop, kneel or crawl.
- Continually required to talk or hear.
- Occasional exposure to moisture via testing.
- Frequently work near moving mechanical parts.
- Occasionally work around fumes, airborne particles, or toxic chemicals.
- Occasional exposure to outside weather conditions.
- Frequent exposure to extreme heat or cold (non-weather).
- Occasional exposure to bloodborne and airborne pathogens or infectious materials.
- While performing the duties of this job, the noise level in the work environment varies from very quiet to loud.
- The employee must occasionally lift and /or move more than 50 pounds.
- Specific vision abilities required by this job include: Close vision and the ability to view products using a microscope.
Benefits
Nextern offers excellent benefits to fuel you in building a fulfilling life and career:
- Fully subsidized basic health insurance for employees + partially subsidized premium and family plans
- Fully subsidized employee dental insurance + optional coverage for spouse/dependents available for purchase
- 401k plan with a company match
- 9 paid holidays (including your birthday!) + dedicated personal and sick days
- Gym membership subsidy
- Employee long-term disability, AD&D and life insurance + opportunity to purchase additional coverage or types of insurance
- Modern facilities with sit/stand desks, flex-work spaces, lots of natural light, and occasionally tacos — because these things are important to productivity
Experience a new way to work with Nextern. We encourage our employees to work with the skills that they are best at while living under company principals. We want to help you leverage your skills to make an impact on a patient’s day-to-day quality of life. We have created a team of creative, caring, and hard-working people that is collaborative and inclusive. We prioritize employees balancing hard work with their own passions outside of the workspace, so that your life isn’t your job title. Come join Nextern, where we are in it TOGETHER!
