Job Description
Device Development Senior Scientist – Development Strategy, Design Controls and Risk Management
Our company’s Device Development (DD) 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 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.
Job description
This position will be responsible for leading and implementing medical device and combination product design controls and risk management activities 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, design control principles and risk management techniques 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
Participate in and support the creation of device development, design controls and risk management strategy for the assigned projects.
Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication within and external to the team, including external suppliers.
Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliers as assigned.
Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
Participate in the preparation of materials for presentation of programs for management and regulatory submission.
Support the development, implementation, and continuous improvement of design controls and risk management processes, procedures, and tools.
Enhance our Company’s 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 5 years of related experience
Experience with design controls and medical device risk management
Proven track record of applying analytical skills in product design, development, and evaluation
Strong project management skills
Self-motivated and work independently
Proven ability to work with multidisciplinary teams
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 multi-task continuously
PREFERRED REQUIREMENTS:
M.A/M.S./Ph.D in one of the above disciplines
Working knowledge of medical device or pharmaceutical industry
Experience with the development of a medical device component of a combination product is an asset.
Experience in a quality role
Experience with device design, requirement management, FMEA, and/or design verification
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.
Working knowledge of ISO 11608 and ISO 11040
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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U.S. Hybrid Work Model
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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 candidate’s relevant skills, experience, and education.
Expected salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
None
