Design Control Engineer III

Role Summary

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.

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

• 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.
• Required: 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.