Design Control Engineer II

Andover, Massachusetts
September 14 2021
Position Type
Full Time
Organization Type
This position will be part of BTx Pharmaceutical Research & Development located at Andover, MA . The incumbent will lead design control projects and create documents for Design History Files and Risk Management Files supporting development and manufacturing of prefilled syringe (PFS), co-packaged and cross labeled combination products to comply with FDA Final Rules on Combination Products. They will interact with cross functional development teams working with all levels of employees.

  • Support the formulation and process development at Andover and St Louis sites to comply with FDA's regulations and guidance documents on Combination Products
  • Lead design control activities, author and review design controls (e.g. requirement specifications) and risk management documents (e.g. FMEA) to support the clinical trials and commercial licensures; Author sections of regulatory filings.
  • Review and /or approve engineering and development documentation such as component drawings and specification, assembly drawings, tolerance stack analyses, change control documents, risk analyses, etc.
  • Review and /or approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
  • Facilitate, support and /or execute verification of device components, and delivery systems
  • Conduct and /or assist investigations of delivery system failures to determine root causes and work with teams to implement appropriate corrective and preventative actions
  • Frequent contact with all levels and functions of personnel

  • BS degreein appropriate Science & Engineering discipline ( Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 2-4years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
    MS degree in appropriate Science & Engineering discipline ( Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 1-3 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
  • Understand Good Manufacturing Practices (GMP)
  • Knowledge of medical device regulations QSR (21CFR Part 820.30 for design controls), ISO 14971 for risk management
  • Understand ISO 11040-4 standard for syringe subassemblies including requirements and testing for Luer lock adaptor and needle shield
  • Capable of working independently with minimal supervision
  • High level of attention to technical details and accuracy
  • Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
  • Demonstrated ability to work collaboratively in cross functional teams
  • Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills
  • Proficiency in general computer software such as word processing, spreadsheets, presentations

  • Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products
  • Experience in Design Controls for Combinations Products
  • Device Risk Management expertise, such as design, process and use FMEAs
  • Understand device design activities, such as thorough understanding of ISO 11040, vendor specifications, user and product requirements, feasibility, characterization and design verification testing, tolerance stack analysis, drawings (components, sub-assembly, final assembly), design validation, design change, design transfer
  • Understand statistical sampling plan, statistical analysis of test results using tools (e.g. Minitab), engineering simulations
  • Familiar with Human Factors Engineering - Usability Engineering
  • Understand project management methodologies and capable to provide technical leadership for projects
  • Familiar with device assembling manufacturing process
  • Ability to perform mathematical calculations and ability to perform complex data analysis.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

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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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