Medical Device - Design Control Senior Consultant

Synergy Bioscience is a quality compliance consulting services provider. We help the FDA-regulated industries address quality compliance-related issues such as FDA Warning Letters and Consent Decrees.

We need a highly skilled Design Control Consultant to help our client with Design Control aspects such as human factors engineering and biocompatibility studies.

Role Summary:
The Design Control Consultant will utilize their engineering, technical skills, and knowledge to assist in the development and remediation of Design History Files (DHF) and ensures compliance with the regulatory requirements for Design Controls and Risk Management. You will also collaborate with other functional teams on researching requirements and owning DHF risk management deliverables to ensure the safety and efficacy of new product submissions.

Role Responsibilities
As a Design Control Consultant, you will create, manage, analyze, and maintain the DHFs, product risk management files (risk planning, risk analysis, risk mitigation, and verification of risk control implementation/effectiveness), and associated documents. You will help support product development and submission activities, including:

• Provide technical support in the development of the Design History File for Combination Products including global regulatory filings, DHFs, risk management, and design controls
• Research device clinical use, standards, and other relevant regulatory guidance for DHF content generation in support of regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and Risk Management per ISO 14971 for the device constituent and drug-device interfaces of combination products.
• Analyze comparable product complaints history and standards for product requirements to create robust design requirements ensuring user needs are met
• Partner with other functions including manufacturing, Safety/Clinical, Human Factors and Design Engineering to develop FMEAs ensuring root causes and errors are identified & mitigated; provide support to risk management activities; provide risk and systems engineering input to cross-functional teams and to instill a spirit of collaboration throughout the organization.
• Supports Combination Product inspection readiness and regulatory responses as needed.
• Participate in focus groups in early use case development to identify unmet needs for design & engineering concept development.
• Support the completion of gap assessments against industry regulations or standards
• Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, inspection readiness.
• Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations by working closely with various departments including Systems, Risk Management, Safety, Clinical, Human Factors, and Design Engineering.

Basic Qualifications

• Bachelor's degree in engineering, physical sciences, or technical writing with 5 years of experience in developing drug delivery devices, combination products and/or pharmaceuticals.
• Basic understanding of engineering principles, system design, and risk management
• Experienced with performing risk assessments using a variety of tools (e.g. FMEA, FTA, etc.)
• Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971, and 21 CFR 820.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure the quality of judgement

Must-Have Qualifications

• The combination of strong pharmaceutical and medical device development experience.
• Extensive experience in risk management and design control of medical devices or combination products from concept through launch.
• Capable of solving technical problems independently and working with minimal direction under most circumstances.
• possess strong oral and written communication skills.
• Experience with medical devices/combination products usability studies, including Formative/Summative studies
• Drafting technical reports; like inceptive/post summative reports
• 10-15 years Human Factors Engineering experience (IEC 62366)
• Experience working with regulatory bodies (FDA, etc.)
• Ability to work within ambiguity
• Capable of adding value to the technical team through insights based on HFE experience

Hourly Rate:

• Negotiable based on the experience.