Senior Principal Scientist – Device Technical And Engineering Lead (senior Director Equivalent)

Sr. Principal Scientist – Device Technical And Engineering Lead (Sr. Director Equivalent)

Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.

This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. This position will lead cross-functional development teams within and external to Device Development & Technology. 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 design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.

Principal responsibilities include:

• Leading and setting direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness.
• Leading the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key functions.
• Leading the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.
• Representing Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).
• Serving as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms.
• Overseeing and serving as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.
• Proactively anticipating and resolving project obstacles and effectively communicating complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers.
• Authoring and reviewing relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Leading/supporting/overseeing clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.
• Leading/supporting the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.
• Maintaining a high level of engagement in the program-specific design controls process and design history file development.
• Staying current with new device technologies, relevant worldwide regulations, standards, and effectively sharing this knowledge with others.
• Enhancing our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities.

Qualifications:

B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development. Advanced degree is preferred. 5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product. 5+ years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams. Experience in development and commercialization of inhalation devices and/or autoinjectors is strongly preferred. Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy. 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, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc. Proven track record of applying analytical skills in product design, development, and validation. Self-motivated with ability to work independently. Proven ability to lead team members of diverse skill 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. Experience with leading complex development projects at an enterprise level. Willing to travel. Able to multi-task continuously.

Required skills include: Business Development, Clinical Strategy, Clinical Supply Chain Management, Communication, Design Verification Testing, Device Development, Ethical Compliance, Human Factor Engineering, Injection Moldings, Intellectual Property Management, Interpersonal Relationships, Machine Learning (ML), Manufacturing Processes, Medical Device Design Control, Medical Device Management, Medical Device Regulations, Medical Devices, Medical Devices Design, Medical Product Development, Negotiation, Process Manufacturing, Product Design.

Preferred skills include: [Skills omitted for brevity]

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $169,700.00 - $267,200.00. 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 employee's 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.