Job Description

Position Description:

Device Development Associate Principal 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.

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

• Lead/contribute to 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 to cross-functional stakeholders, 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

• 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 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

Position Qualifications:

Education Minimum Requirement:

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experience

Required Experience and Skills:

• 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 and risk management 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

• Self-motivated 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 multi-task continuously

Preferred Experience and Skills:

• Master's 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 drug-device 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

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.

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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:

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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.

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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, Monday - 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".

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 candidate's relevant skills, experience, and education.

Expected US salary range:

Available 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 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*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.

Requisition ID:R309726