Device Development Senior Scientist – Development Strategy, Design Control and Risk Management

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Position will be responsible for leading and implementing Medical Device and Combination Product Design Control and Risk Management activities for both inline products and new products form early design concept definition through commercialization.

This position will interact with cross-functional development teams and within 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.

Principal Responsibilities

• Participate in and support the creation of Device Development, Design Control and Risk Management strategy for the assigned projects

• Lead the implement and/or ensures effective execution of the Device Development Strategy, Design Control 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.

• Lead the implementation and communication of Device Development Strategy, Design Control and Risk Management procedures within Device Development and with external suppliers as assigned

• Understand and applies regulatory / compliance requirements relative to Design Control and Risk Management activities.

• Participate in preparation of materials for presentation of programs for management and regulatory submission

• Support the development, implementation and continuous improvement of Design Control and Risk Management processes, procedures and tools

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 device design and/or device verification.

• Proven track record of applying analytic skills in the 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. in one of the above disciplines.

• Working knowledge of medical device or pharmaceutical industry.

• Experience in a quality, design control, risk management role.

• Experience with the development of a medical device component of a combination product is an asset.

• Knowledge with U.S. and global Medical Device and healthcare regulations, including FDAs combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

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Flexible Work Arrangements:

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Requisition ID:R205000