Design Control Engineer III

Biologics Modalities Design Control Leader

This position will be part of BTx Pharmaceutical Research & Development located in St. Louis, MO or Andover, MA. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees.

Role Responsibilities

• Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external.
• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Provide input and support for design validation, including but not limited to human factors engineering assessments.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support internal and external audits of the DPDD Quality System.

Qualifications

Must Have

• BS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 6 to 8 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.

OR

• MS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 4 to 6 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.

• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive.

• Working knowledge of EN 62366 and EU Medical Devices Regulation.

• Capable of working independently with minimal supervision

• High level of attention to technical details and accuracy.

• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.

• Able 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.

• Understand Good Manufacturing Practices (GMP)

Nice To Have

• 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

• Understand statistical sampling plan and statistical analysis of test results.

• 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.

The annual base salary for this position ranges from $77,100.00 to $128,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. 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.

Relocation assistance may be available based on business needs and/or eligibility.