Sr. Device Engineer Job Camden area,New Jersey USA,Engineering

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

At Pfizer, we believe that every role contributes to our mission of improving patients' lives.

Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.

What You Will Achieve

In this role, you will:

Be responsible for device lifecycle management of on-market medical devices and combination products.
Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
Lead device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained
Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues
Lead design change projects according to internal procedures, track progress, and communicate status to group leadership
Establish experimental protocols, conduct experiments, analyze results
Lead technical execution of Design History File (DHF) updates
Establish and maintain relationships with internal production site colleagues
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, with guidance and supervision.
Ensure the design controls are documented in accordance with internal procedures.
Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
Support CAPA and Complaint investigations, as appropriate

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
OR an associate's degree with 6 years of experience; OR a high school
diploma (or equivalent) and 8 years of relevant experience.
Demonstrated 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 related 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

Bonus Points If You Have (Preferred Requirements)

Relevant pharmaceutical experience
Proficiency in continuous improvement and Statistical Process Control methodologies, such as DMAIC and Six Sigma
Familiarity with a wide range of package performance testing equipment and methods
Understanding of regional pharmaceutical compendia testing requirements
Excellent communication and interpersonal skills
Strong organizational skills and attention to detail
Demonstrated leadership capabilities and mentoring skills
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk…