Principal Scientist, Drug/Device Combination Products Full-time

Medical Device Design Control Manager

This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971).

This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements.

Principal Responsibilities

• Lead/support continuous improvement initiatives for design control and risk management processes
• Identify and eliminate process inefficiencies using operational excellence tools
• Develop training materials to foster a culture of operational excellence
• Ensure processes align with regulatory requirements for medical device and drug combination products (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971)
• Collaborate with cross-function teams to improve processes related to device-drug integration.
• Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.
• Leverage data analytics and key performance indicators to monitor process performance.
• Support internal audits, regulatory inspections, and third-party audits.
• Conduct structured assessments of key quality and compliance programs to identify gaps against internal standards, regulatory expectations (e.g., FDA, EMA), and industry best practices, generate action plans and drive the plan to closure. Develop actionable remediation plans and drive their execution through to closure.
• Lead/contribute to device development, design controls for the assigned projects.
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
• Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.
• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.

Position Qualifications:

Education Minimum Requirement: B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 15 years of related experience or master's degree in one of the above disciplines plus 12 years related experience

Required Experience and Skills:

• 10+ years of experience in process improvement, Quality management system, operational excellence, and product development
• Has broad knowledge of combination product/medical device development, design controls, and risk management
• Hands-on experience with combination products
• Proven track record of driving lean and six sigma initiatives in a regulated environment
• Led and managed development of DHF (design history file) deliverables for combination products and/or medical devices
• Knowledge of U.S. and global combination product/medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
• Self-motivated with the ability to work independently.
• Experience with FMEA, statistical sampling, and control strategy.
• Proven ability to work with team members of diverse skill sets and backgrounds.
• Strong analytical and problem-solving abilities.
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
• Demonstrated experience leading and supporting change initiatives, with a strong track record of driving process improvements and fostering cross-functional collaboration to achieve sustainable results.
• Excellent communication, presentation, negotiation, project management, and organizational skills.

Preferred Experience and Skills:

• PMP or similar project management certification
• Quality Engineering Certification
• Six Sigma Certification
• Experience with device design, process development, design verification, and design validation

Required Skills: Biomedical Engineering, Combination Products, Device Development, Process Development Engineering, Process Improvements, Product Development

Preferred Skills: