Senior Design Assurance Engineer
Role details
Job location
Tech stack
Job description
This position is responsible for providing Design Assurance support to product development activities, selected sustaining, and specials projects within Orthofix. The position must also ensure compliance with applicable product standards, governing laws and regulations, and company quality system requirements., The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
- Participate as a product development cross-functional core team member.
- Ensure project design controls requirements are being met.
- Educate and guide product development team on quality and design controls best practices.
- Collaborate with multiple disciplines to ensure completion of project objectives.
- Risk management and hazard analysis.
- Reliability and failure analysis, FMEAs
- Design validation plan and protocol development.
- Evaluate design changes for impact to standards and product essential performance.
- Establish acceptance criteria and ensuring compliance with technical standards.
- Biocompatibility and Sterilization
- Review specifications to ensure appropriate dimensioning and tolerances.
- Input to process development and design for manufacturing.
- Input to and approval of process validation activities.
- Measurement System Analysis
- Input to, and development of, specifications, standards, test protocols, test reports, procedures and other documentation and records related to design and development.
- CAPA/NCMR investigations
Requirements
- Bachelor's degree in mechanical or electrical engineering
Experience, Skills, Knowledge and/or Abilities:
- 5-10 years of relevant experience
- Root cause analysis, problem solving, continuous improvement.
- Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
- Excellent time management and ability to balance multiple deliverables simultaneously.
- Logical cognitive skills and ability to apply scientific methods.
- Ability to identify variables affecting quality.
- Ability to meet deadlines and/or objectives as directed., * ASQ Certified Quality Engineer (CQE)
- Master's degree in engineering
Additional Experience, Skills, Knowledge and/or Abilities:
- Software design, IEC 62304, cybersecurity
- Worked with Spinal or Orthopedic medical devices.
- Medical device or other health-related field experience
- CAD
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
- This position requires frequent light lifting of up to 15lbs.
- This position requires frequent repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.
The anticipated salary for this position for an employee who is located in California is $122,700 - $149,000 per year, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.
