Summary
Cionic builds wearable solutions that provide comprehensive analysis and precise augmentation to enhance human performance and improve quality of life. Our devices push the limits of integrated hardware and software design, emphasizing functional wearability and personalized intelligence. In this role, you will be part of a fast-paced startup taking products from concept to market.
Key Qualifications
- 5-7 years of experience in medical device Quality or Manufacturing Engineering
- Understanding of 21 CFR Part 820 QSR regarding quality systems for medical and commercial regulatory requirements
- Must have utilized CAPA, SCAR, or 8D method for corrective/preventive actions following medical device guidelines
- Must be able to develop and execute PPAP-type process qualification protocol and participate in the development of FMEA and Control Plans for medical devices
- 3 years of experience in Product Development or Design Transfer
- Strong electro / mechanical background (i.e., with 60601-1 experience) required preferably with PCB & PCBA, plastic molding, cable assembly, and box-build integration
- Practical skills in descriptive statistics, SPC, Cpk, GRR, c=0, ANSI Z1.4, PPM/DPMO
- Required to read and interpret mechanical drawings
- At a minimum, build pivot tables, and trend data, perform formula calculations, export/import data, write procedures, generate customer-facing presentations, and build relevant workflows or Process Flow Diagrams
- Required to be proficient in the English language, possess effective verbal and written communication, and use professional e-mail etiquette
- Bachelor's degree in Engineering (Electrical or Mechanical) or related subject is required
- DHF maintenance, DMR/DHR development, and defining and executing process qualifications
- Apply QMS standards and practices for compliance with customer and regulatory requirements
- Assist in, and drive to closure, customer product complaints, nonconformances, internal audit findings, and CAPA resolution
- Familiar with Part 803 adverse event reporting (MDRs) and Part 806 correction/removals guidelines
- Although you are not directly responsible for managing other employees, you could participate in candidate interviews
- Ensure and implement all production corrective and preventive actions as required
- Contribute to the Management Review and QMS maintenance/improvement efforts
- Drive PPM reduction opportunities for products by collecting and reviewing non-conformance data from internal data sources (e.g., incoming, production, customer returns, SCAR)
- Provide insight and assistance in implementing process improvements concentrating on proactive methodologies with the Engineering and Production functions
- Provide regular updates on customer monitoring, trends, and improvements internally, to the Customer Focus Teams, and to the customer where applicable
- Adhere to all safety and health rules and regulations associated with this position and as directed by organization policy
- Comply and follow all procedures within the company security policy
- May perform other duties and responsibilities as assigned
- Work with QA and Operations personnel to strengthen the manufacturing process and the QMS in Operations
- Participate in FDA inspections as SME for company QMS and overall compliance to Part 820
- Provide/coordinate training to company as needed regarding QMS and medical device requirements
Ready to apply? Reach out to us at hiring@cionic.com.