Let's do this. Let's change the world. In this vital role you will perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product's life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures.
Office-based role supporting virtual teams via Webex and phone.
Flexibility required when working with global colleagues in various time zones.
Must be able to travel up to 5% - Would be to Phoeniz AZ if required
Key Responsibilities • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues • Establish experimental protocols, conduct experiments, analyze results • Support technical execution of Design History File (DHF) updates • Establish and maintain relationships with manufacturing site colleagues • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes • Establish and review specifications/requirements for components, products and processes • Support CAPA investigations • Ensures product conforms to current relevant international standards • Support multi-functional assessment of complaint record
Preferred Qualifications • Bachelor's degree in Engineering, Science or other technical degree • 1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role • Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products • Experience analyzing patient/user impact • Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards • Critical thinking, and problem-solving skills • An ability to work independently as well as a member of a team in a fast-paced environment • Working knowledge of statistical methods for data analysis • Familiar with microcontroller-based firmware, software verification (unit, static, dynamic • analysis) • Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields • The position requires excellent organizational, technical problem solving and communication • skills (written and verbal) and the ability to lead external teams
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
? Medical device industry experience and regulated work environment experience
? Medical Device Design Controls experience
? Root cause analysis experience
Day to Day Responsibilities: • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues • Establish experimental protocols, conduct experiments, analyze results • Support technical execution of Design History File (DHF) updates • Establish and maintain relationships with manufacturing site colleagues • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes • Establish and review specifications/requirements for components, products and processes • Support CAPA investigations • Ensures product conforms to current relevant international standards • Support multi-functional assessment of complaint record