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Pfizer · 1 hour ago

Design Control Engineer III

Andover, MA

Full-time

Onsite

Mid, Senior Level

$77K/yr - $128K/yr

4+ years exp

Pfizer is a leading pharmaceutical company, and they are seeking a Design Control Engineer III to lead design control projects for biologics modalities developed as prefilled syringe-based combination products. The role involves ensuring compliance with quality and regulatory standards and supporting various design control and risk management activities.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

U.S. Citizen Only

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

Qualification

BS/MS in Science/EngineeringISO 9001ISO 13485ISO 1497121 CFR 820EU Medical Devices DirectiveDevice Risk ManagementManufacturing PracticesHuman Factors EngineeringStatistical analysisProject managementGeneral computer softwareTechnical leadershipAttention to detailCommunication skillsTeam collaboration

Required

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)

Preferred

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