Team Leader, Lifecycle Development & Engineering

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 will help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

The Lifecycle Development Engineering Team Leader (LDETL) provides technical project leadership and operational excellence for the execution and delivery of Medical Device & Combination Product (MDCP) projects from mid to late-stage development through launch.

The LDETL serves as an operational technical leader, ensuring required MDCP deliverables (e.g. Design History File, Risk Management File, etc) are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The LDETL uses leadership and interpersonal skills to motivate and influence team members to high team performance and individual achievement. The LDETL’s responsibilities encompass strategic problem-solving, project planning, compliance, program execution and delivery, team effectiveness, risk management, and communication management. This role is an individual contributor leader position.

How You Will Achieve It

• Accountable and responsible for all aspects in the development of MDCPs and life cycle management activities
• Lead, manage and co-ordinate the activities of GT&E colleagues and external partners with respect to:
  • Project Scope and Deliverables
  • MDCP Specifications
  • Design Development
  • Concept Evaluation
  • Design Control
  • Risk Management
  • MDCP Industrialization/Process Development & Design Transfer
  • Design Verification
  • Design Validation
• Apply design control and risk management to MDCP projects and to support MDCP colleagues in ensuring compliance to Pfizer policies and procedures.
• Support the generation and approval of project and departmental budgets in collaboration with Launch Excellence
• Collaborates with technical team to provide input to supplier specifications for devices and device components
• Provide input and support to human factors usability studies
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities and procedures to support MDCP development and supply
• Support technical SMEs in the MDCP development process.
• Provide support as required to regulatory correspondence, IND, BLA, NDA, and ANDA filings. (multi-market)

Qualifications

Must-Have

• Bachelor ‘ s Degree and 7 + years of experience .
• Mastery of project management skills and product development. Minimum of 3 years in Project Management / Leadership.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address project-related issues
• Planning experience and fiscal awareness are essential, as is a sustained record of satisfactory performance
• Technical abilities should include a sound knowledge of the medical device development process; an advanced technical knowledge within the applicant’s own discipline as well as a strong knowledge of other related disciplines
• Demonstrated skills in planning, scheduling, forecasting, including the use of relevant digital tools.
• Demonstrated influencing and negotiating skills; and proven skills in developing others within own functional area.
• Ability to identify and develop options to support short to mid-term goals and set direction for team.
• High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

Nice-to-Have

• Strong understanding of and experience in combination product development (drug plus device) highly preferred.
• Medical device development/design controlexperience preferred.
• Strong track record of performance on cross-functional teams and results through effective implementation of project management methodology, tools, and techniques.
• Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
• Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders.
• Demonstrated ability to utilize project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis).
• Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines
• Track record for delivery against challenging personal and team goals.

PHYSICAL/MENTAL REQUIREMENTS

The successful candidate will be capable of independent problem solving and working with minimal direction under most circumstances. Applicants should demonstrate strongly collaborative behaviors and teamwork and demonstrate expertise in most or all of the following: team dynamics, coaching, negotiation, motivating and other soft skills necessary to foster team effectiveness in a matrixed environment. The successful candidate will also possess strong oral and written communication skills. Strong analytical and computer skills are required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Typically less than 20% of travel. May be higher dependent on project and timing within project.

Relocation support available
Work Location Assignment:Flexible

Last date to apply: 1/26/2024

The annual base salary for this position ranges from $117,300.00 to $189,700.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits tendersglobal.net (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.

Engineering

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