Job Description
We have an exciting opportunity for a Senior Specialist position in the Device Technology group within our company's Pharmaceutical Science and Clinical Supply organization. The focus of the role is on the development and commercialization of our company's pediatric combination product portfolio, including the identification of requirements, specification of components, management of verification of testing strategies, and transfer of design to production sites. Using the frame works of design controls, medical device risk management, and usability engineering, the combination product engineer is responsible for gathering user and design requirements, planning design activities, ensuring that the design meets all requirements and transferring processes and knowledge to manufacturing and sustaining teams. Leveraging technical knowledge and intra-personal skills, the combination product engineer is responsible for meeting file and launch on-time goals, as well as ensuring that risks are appropriately identified and mitigated. The Sr. Specialist is accountable for either sole or shared project leadership, as well as providing ad-hoc support to development teams based on skills or need. The Sr. Specialist is accountable for authoring technical documentation, leading team based technical reviews or design review, authoring regulatory submissions, and responses to audit or regulatory comments.
Principal Responsibilities and Requirements

• Authors Design Control documents and leads other individuals on supporting documentation requirements.
• Effectively lead project team to support the combination product development with focus of device selection and integration.
• Supports Device Risk Management, Human Factors Engineering, and Biocompatibility assessments.
• Familiarity with Pharmaceutical or Medical Device manufacturing operations.
• Drive laboratory testing, verification testing, or quality attribute testing.
• Support human factors engineering, usability engineering, human centered design or other customer focused methodologies.
• Provide insight into process validation testing.
• Author documentation to support regulatory agency interaction and responses.
• Solicits feedback to ensure that customer/stakeholder needs are the cornerstone of decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.

Education/ Experience

• Required: B.S. or higher (MS or PhD) in Biomedical Engineering, Mechanical Engineering, Polymer or plastic engineering or related discipline
• 5+ years of experience in medical device, pharmaceutical or in biotech organizations, will consider M.A/M.S. with at least three years of related experience or PhD with one year of related experience of the above disciplines

• Required Experience and Skills:
• Knowledge of 21CFR 820, part 4, ISO 13485.
• Proven track record of applying analytic skills in the product design, development, and evaluation.

• Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.
• Independent, self-driven, capable of working independently.
• Previous experience leading cross-function project teams.
• Knowledge of injecting molding process
• Proven ability to work with multidisciplinary teams.
• Excellent communication, presentation, negotiation, project management and organizational skills.

• Working knowledge of medical device or pharmaceutical industry.
• FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
• Willing to travel up to 10%

NOTICEFORINTERNALAPPLICANTS
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 separation package, 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.
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.
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
$101,100.00 - $159,100.00
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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:05/15/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R292905