Senior Principal Device Technical Working Group Lead (Senior Director Equivalent)
Senior Principal Device Technical Working Group Lead (Senior Director Equivalent)
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$ 169700 - 267200
1 Vacancy
Job Description
Job Description
Sr. Principal Scientist Device Technical and Engineering Lead (Sr. Director Equivalent)
Our companys Device Product & Process Development 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 Device Product & Process Development Team manages the development of the device constituent of our companys pipeline of combination products across a variety of therapy areas and routes of administration including inhalation implantation and injection.
Job Description
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 subjectmatter experts on the Device Product & Process Development team and members of internal crossfunctional 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 crossfunctional 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
Lead and set direction for the device development strategy for multiple drugdevice combination product development programs ranging from concept generation/selection development verification and validation to launch readiness:
Lead the crossfunctional Device Working Groups to ensure full integration of the device development activities with the clinical regulatory formulation commercial and other key company functions.
Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.
Represent Device Development and the projectspecific Device Working Groups on crossfunctional teams including the Development and Commercialization Team (DCT). Additionally maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).
Serve as key pointofcontact with potential external device designers developers and suppliers for selected device technology platforms.
Oversee and serve 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 anticipate and resolve project obstacles and effectively communicate complex product technical challenges device development strategy timelines milestones and risks within our Company and with external suppliers
Author and review relevant portions of the regulatory submissions (INDs IMPDs NDAs BLAs etc.) for combination product programs under your leadership.
Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.
Lead/support the development implementation and continuous improvement of Device Development and Device Project Leader processes procedures and tools.
Maintain a high level of engagement in the programspecific design controls process and design history file development.
Stay current with new device technologies relevant worldwide regulations standards and effectively share this knowledge with others.
Enhance our Companys professional image and competitive advantage through publications presentations patents and professional activities.
Qualifications
REQUIREMENTS:
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 drugdevice 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 crossdisciplinary project teams.
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 ISOand 11040 EN 62366 Council Directive 93/42/EEC etc.
Proven track record of applying analytical skills in product design development and validation
Selfmotivated 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 multitask continuously
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$169700.00 $267200.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/15/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Exec
Employment Type
Full-Time
