Risk Lead, Device Engineering Lifecycle Management - Pfizer Canada Inc.

Compensation

: $111,680.00 - $166,760.00 /year *

Employment Type

: Full-Time

Industry

: Pharmaceutical/Biotechnology



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ROLE SUMMARY

The Device Engineering Lifecycle Management Risk Lead is responsible for global Medical Device and Combination Product lifecycle management including product and process change management and risk management. Responsible to maintain compliance between the on-market product and the Design History File (DHF). Cross divisional and PGS Site facing role to establish activity priority and communicate deliverables and timing. This position, will partner with clinical affairs, medical affairs, safety, quality, and the manufacturing site colleagues in the assessment of patient, product, and process risk.

ROLE RESPONSIBILITIES

  • Provide technical guidance for device changes, document updates, process changes, risk management
  • Expert in risk analysis and risk management tools, techniques, and methodologies
  • Facilitate patient risk assessment and rationale with key medical, clinical, safety, quality, and site stakeholders
  • Create and plan risk assessment activities, track progress, and communicate status to management
  • Train PGS site, clinical, medical, and safety colleagues on product and process risk management activities for product lifecycle
  • Accountable for the risk management for products and deployment / maintenance of risk management review process
  • Facilitate marketed product maintenance process with clear roles and responsibilities for Center functions, Site, Quality, Engineering, and R&D functional units
  • Develop and manage network-wide project prioritization
  • Support technical issue resolution associated with medical device and combination product risk assessments
  • Support day to day support for design changes, complaints, CAPA, management review
  • Report and escalate to leadership as needed
  • Communicate technical risks to key stakeholders at production sites and within central functions
  • Establish and maintain relationships with production sites and key stakeholders
  • Ability to effectively manage and influence global cross functional teams
  • BASIC QUALIFICATIONS

  • Bachelor s degree in Packaging, Mechanical, Chemical, Biomedical or related Engineering Science is required. Advanced degree desirable.
  • 10 years experience in Device Design, Quality Engineering, Pharmaceutical Package Engineering, Package Design or equivalent Technical Project Management preferred
  • 5 years experience in Medical Device and Combination Products Design Controls, Production, Sustaining Engineering role, Risk management or related field preferred
  • Practical application of Risk Management tools
  • Practical application of analyzing complex issues for patient/user impact
  • Thorough understanding and in-depth knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
  • Practical expertise in production and production systems in a GMP regulated environment
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

  • PREFERRED QUALIFICATIONS

  • Expert technical expertise in risk management and associated tools for patient, user, design, and process risks
  • Proven project management and complex problem solving skills
  • Excellent relationship management, communication and presentation skills
  • Excellent verbal, written and interpersonal communication skills
  • Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives
  • Demonstrated leadership with proven success in challenging status quo
  • Strong organizational and planning skills, as well as a high energy level and initiative
  • Ability to work independently and as a member of a team and in collaboration with other functional groups
  • Strong technical knowledge of complex Medical Device and Combination Products technologies
  • Ability to advance new processes and moderately complex methodologies
  • Agile learner of new processes and capable of developing / executing again immature processes
  • Strong technical project manager, critical thinking, and problem solving skills
  • PHYSICAL/MENTAL REQUIREMENTS

    Office-based role supporting virtual teams via webex and phone. 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 30%

    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.


    Associated topics: bioinformatic, biomaterials, biomedical, biomedical engineer, bioprocessing, biosynthetic, molecular, msat, neurodegenerative, pain * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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