The Medical Device Combination Product Software Validation AD will be responsible for Software Quality and Validation activities including the review of Use and Functional Device Requirements, Design Specifications, review and approval of test protocols and reports, Validation Plans and Reports, Trace Matrices, and process validations related to Software as a Medical Device. Ability to create and meet deliverables per Project Schedule and support teams advising on the correct cGMP approach to allow software analysis and criteria assessment prior to product acceptance testing, a mandatory prerequisite for new product commercialization.
This position will be an individual contributor role on the Medical Device and Combination Product Quality team. Reporting to the Director MDCP Quality Assurance, this role is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business and systems to ensure compliance with FDA Medical Device Regulation (21CFR 820), Combination Products Regulation (21CFR Part 4), Device Risk Management (ISO 14971), IEC 62304:- Medical Device Software Lifecycle and other worldwide regulations and company requirements.-
This position provides Software Device Quality Assurance support to ensure successful quality oversight of prospective Medical Devices and the device constituent part of Combination Products to meet Health Authority (HA) regulations, international standards, and company procedures.
Key Functions
Minimum Education and Experience Requirement
Required Experience and Skills
Preferred Experience and Skills
Demographics:
This position follows a Hybrid work model.
U.S. Hybrid Work Model
Effective September 5, 2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.-
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 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
Secondary Language(s) Job Description
Same as Primary Posting Language
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your Rights
EEOC GINA Supplement•
Pay Transparency Nondiscriminatio n
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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.S. Hybrid Work Model
Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, 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:
$130,960.00 – $206,200.00
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 .
Learn more about your rights, including under California, Colorado and other US State Acts
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:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st – Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Requisition ID:R250656
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