Device Development Associate Principal Scientist Development Strategy Design Controls Associate Director Equivalent
Device Development Associate Principal Scientist Development Strategy Design Controls Associate Director Equivalent
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
Device Development Associate Principal Scientist Development Strategy Design Controls
(Associate Director Equivalent)
Our companys Device Development & Technology (DD&T) 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 DD&T 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 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 postmarket surveillance.
This position will interact with crossfunctional 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 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 of the device development strategy and design controls for the assigned projects while adhering to managementapproved strategic plans corporate policies and providing clear communication to crossfunctional 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 10 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
Selfmotivated and work independently
Proven ability to work with 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
Willing to travel
Able to quickly pick up advanced domain knowledge
Able to multitask continuously
PREFERRED REQUIREMENTS:
Masters degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experience
Experience with the development drugdevice 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
PSCS
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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 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:
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 anothers thinking and approach problems collectively.
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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:
$139600.00 $219700.00Available 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
Search Firm Representatives Please Read Carefully
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:
YesTravel Requirements:
10Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/13/2025*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:
Director
Employment Type
Full-Time
