Manager, Combination Products Engineer
Location:
Kansas City , Missouri
Posted:
November 23, 2017
Reference:
1719124461

ROLE SUMMARY Leads life cycle maintenance, design, and development work to support the sites auto injector platforms at the St. Louis MO site to support FDA's Guidance on Combination Products. Manages design concepts, ideas for product improvements and the creation of technical impact assessments / risk assessments as well as developing verification plans, test methods and data analysis of products at the site. Manages the development of prototype parts in support of design concepts to be used in engineering testing and evaluations. Manages the design, development, and/or fabrication of test fixtures/test items. Manages the creation of SOPs, test protocols and laboratory research reports as needed. Manages the documentation of laboratory testing protocols and results as per corporate policies. Reviews research in market assessment or clinical and user studies. Responsible for documentation of development work in a Design History File for all product development. ROLE RESPONSIBILITIES Support the Product Technology team and sites efforts to comply with FDA's regulations and guidance documents on Combination Products Develop technical impact assessments for changes and develop execution plans Develop risk assessments, risk mitigation strategies and risk management plans Draft/Update/Review and Approve Design History File documentation Utilize Design History File documents to assess changes or modifications to existing auto injector platforms and to make recommendations for enhancements based on information obtained from the market place, suppliers or manufacturing. Develop and evaluate conceptual design changes or enhancements for existing auto injector products Create or review/approve engineering and development documentation such as product requirements, detail drawings, assembly drawings, tolerance stack analyses, change orders, risk analyses, etc. Write/Review/Approve test protocols and reports using design control procedures and policies Facilitate, support and /or execute verification of device components and / or delivery systems Provide technical leadership in investigations of delivery system failures to determine root cause and work with teams to implement appropriate corrective and preventative actions Provide input and feedback on new drug delivery systems to R&D and other technical teams Review/Approve test fixtures or components Perform/Review Combination Product technical assessments Review/Approve engineering prototypes for design concepts QUALIFICATIONS EDUCATION AND EXPERIENCE Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Materials, Chemical or Manufacturing Engineering preferred with a minimum of 5 years' experience in the Pharmaceutical Combination Products or Device industries. TECHNICAL SKILLS REQUIREMENTS Required: Conceptual design skills Experience in complying with FDA quality system regulations and EU medical device directives Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, project planning etc. Strong mathematical, analytical, and reasoning skills Strong creativity and innovation skills Strong research skills Strong organizational skills Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously Responds to requests for service and assistance with professionalism, courtesy, and confidence Strong in team work Capable of working independently with minimal supervision Strong oral communication Strong written communication Strong presentation skills High level of attention to detail and accuracy Understanding of Combinations Products Regulations and Design Controls Preferred: An appreciation of business acumen - demonstrates knowledge of market and competition An appreciation of Human Factors Engineering - Usability Engineering 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. Must be able to travel 25% of the time. The noise level in the work environment is usually moderate. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 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. Note that these activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively under 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. Must possess a high level of manual dexterity 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. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees. 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. Additional Offer Details: Last Date to Apply for Job: November 27, 2017 This job is Pfizer Exempt US Grade: 012 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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