Senior Device Engineer

ROLE SUMMARY

Works as a device engineering team lead or member/lead of cross-functional teams, as well as independent contributor throughout the Combination Product Life Cycle process. Performs or oversees engineering, design, and development work. Develops design concepts and ideas for product improvements. Develops prototypes of design concepts for engineering testing and evaluation. Reviews/approves SOPs, test protocols, laboratory research reports and provides laboratory oversight as needed. Responsible for adhering to design controls and documenting all product development work in a Design History File.

ROLE RESPONSIBILITIES

• Lead design control, change management and risk management activities related to the combination device, design and manufacturing process ensuring compliance to all applicable regulations
• Performs or oversees biomedical/mechanical engineering, design and development work, including design concepts and product improvements, drawings, tolerance stacks and engineering analyses
• Develops prototypes of design concepts for engineering testing and evaluation
• Reviews/approves/creates SOPs, test protocols, laboratory test reports and risk-based plans for verification and validation testing
• Performs human factors (usability studies), market assessment, or pre-clinical research
• Support technical execution of Design History File (DHF) enhancements/updates
• Liaison with internal production sites, quality, regulatory, medical, clinical, Co-Development, and Tech Transfer/Launch Teams
• Establish and maintain relationships with production sites and key stakeholders
• Technical oversight of other engineers

BASIC QUALIFICATIONS

• Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field
• B.S. Degree in Engineering discipline with 7 - 9 years' experience
• M.S. Degree in Engineering discipline with 5 - 7 years' experience
• Ph.D. in Engineering discipline with 3 - 5 years' experience

PREFERRED QUALIFICATIONS

• Strong technical project manager, critical thinking, and problem-solving skills
• Strong communication and collaboration skills
• Thorough understanding and in-depth knowledge of FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30, ISO 13485 and ISO 14971 and related standards, and EU Medical Device Directives
• Understanding of production and production systems in a GMP regulated environment
• Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Ability to prioritize multiple responsibilities and to work on multiple complex technical projects simultaneously

PHYSICAL/MENTAL REQUIREMENTS

The employee is regularly required to sit, talk or hear, stand and walk. Lifting boxes of 20 lbs. Specific vision abilities required by this job include ability to adjust focus. The noise level in the work environment is usually moderate.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to travel 25% of the time.
• Position requires regular onsite attendance; however, this position may be performed on a remote or telecommute basis on a temporary, short term basis.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.
• Flexibility required when working with global colleagues in various time zones.
• Must have the ability to work effectively under pressure and manage to strict production, time and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.

Last Date to Apply for Job: May 11, 2021

Eligible Employee Referral Program

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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.

Research and Development

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