R&D Engineer

We are looking for a creative thinker — someone who takes a logical approach to solving problems and the product development process.

• Interpret product requirements and develop appropriate test methods and acceptance criteria that verify requirements were met.
• Author and execute verification and validation protocols and report using statistical tools and methods.
• Contribute to common risk management techniques (FMEA, FTA, SHA).
• Use statistical techniques to analyze, summarize, and communicate test results and data.
• Conduct experiments using common DOE and statistical analysis tools.
• Design, execute, and interpret experiments, including basic aptitude in statistics.
• Participate in periodic design reviews of projects.

• Improve patient outcomes.
• Meaningfully impact the company's short-term and long-term success.
• Work closely with executives across the organization.
• Grow your role as you see fit.
• Learn everything there is to know about respiratory medical device manufacturing.
• Create an inspiring workplace.

• 4–6 years relevant work experience.
• Experience with medical product development or other highly regulated environments highly preferred (ISO requirements, GMP/GDP guidelines, FDA regulations, International regulation, and medical device design control).
• Working knowledge of international standards applicable to medical devices, including ISO
  13485, ISO
  14971, and IEC
  60601 and its collateral standards.
• Experience working with engineering and other professionals in a cross‑functional matrix organization.
• Work independently, be a key problem solver and work with teams internally & externally to procure required materials and services.
• Team player by nature with the ability to work independently with a result‑oriented “can‑do” attitude.
• Working knowledge and proficiency using Solid Works for 3‑D design & development, including the ability to create, interpret, and utilize 2‑D drawings to capture specifications.

• B.S. in mechanical, plastics, biomedical engineering, or equivalent.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.