Principal (Staff) Device Engineer Job at Pfizer
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Principal (Staff) Engineer responsible for sustaining on-market Invitro Diagnostic (IVD) device through product / process change and risk management activities.
Production site and R&D facing role. Primary responsibilities include facilitating product launch, leading post-market changes and identifying opportunities for continuous improvement.
This is an onsite position that will be located in San Jose or Emeryville, CA.
How You Will Achieve It
- Lead design changes, process changes and risk management updates. Track progress and communicate status to management.
- Guide, motivate and/or oversee the activities of individuals and teams with focus on project/program issues.
- Liaison between the local production, lab, and R&D sites, Regulatory, and Quality colleagues
- Plan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory Affairs
- Establish and review specifications / requirements for components, products and processes
- Identify Design History File (DHF) enhancements / updates for specific device presentation / platform
- Assess trends in post-market surveillance and production controls to identify and execute continuous improvement activities for device presentation / platform and processes
- Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective and preventive actions
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met
- Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding
- Contributor to Annual Product Record Review
- Represent device engineering on change / CAPA review board, as needed
Qualifications
Must-Have
- Must have a High School Diploma (or Equivalent) and 10 years of relevant experience
- OR an Associates degree with 8 years of experience
- OR a Bachelors, Mechanical, Biomedical, Chemical or Manufacturing Engineering or related science discipline, with at least 5 years of experience
- OR Masters Degree with more than 3 years of experience
- OR a PhD with 0+ years of experience.
- Experience in Medical Device Design Controls or related area
- Experience analyzing patient/user impact
- Experience in a GMP regulated industry
- Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, ISO 62304, ISO 62366 and related standards
- Ability to advance new processes and moderately complex methodologies
- Strong technical, critical thinking, and problem-solving skills
- An ability to work independently, guide others and serve as an effective member of a team in a fast-paced environment
- Excellent communication skills (written and verbal) and attention to details
PHYSICAL/MENTAL REQUIREMENTS
Office-based role supporting virtual teams via webex and phone.
Flexibility required when working with global colleagues in various time zones.
Flexibility required when working with global colleagues in various time zones.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to travel up to 20%
Other Job Details:
- Last Date to Apply: May 24, 2023
- Relocation assistance eligible: Yes
- Employee referral eligible: Yes
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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