Principal Scientist, DrugDevice Combination Products

Job Description

Job description

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 masters 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:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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