Principal Scientist, Combination Products Inhalation Devices

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.

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. 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/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.

• Lead the preparation of materials for program presentations for management review and regulatory submission.

• Contribute to the development implementation and continuous improvement of design controls processes procedures and tools.

• Enhance our Companys professional image and competitive advantage through publications presentations patents and professional activities.

• Stay current with relevant regulations technologies standards and effectively share this knowledge with others.

Qualifications

MINIMUM REQUIREMENTS:

• B.A./B.S in Mechanical Engineering Biomedical Engineering Industrial and System Engineering or other types of engineering plus 15 years of related experience

• Has broad knowledge of medical device development design controls and risk management

• Led and managed development of DHF (design history file) deliverables for medical devices

• Recognized as a subject matter expert in at least one medical device development or design controls area

• Knowledge of U.S. and global 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.

• Proven track record of applying analytical skills in product design development and evaluation

• Self-motivated and work independently

• Proven ability to work with team members of many skills sets and backgrounds

• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership

• Excellent communication presentation negotiation project management and organizational skills

• Able to quickly pick up advanced domain knowledge

• Able to multi-task continuously

PREFERRED REQUIREMENTS:

• Masters degree in one of the above disciplines plus 12 years related experience

• Experience with the development drug-device combination product or a medical device component of a combination product

• Experience with leading development projects at an enterprise level

• Experience with device design requirement management FMEA design verification design validation statistical sampling and control strategy

• Experience with regulatory fillings

• Working knowledge of ISO 11608 and ISO 11040

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.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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