Specialist, Drug/Device Combo Products (Hybrid)

Job Description

We are seeking a Growth and Improvement minded Engineering Specialist | Device & Packaging Technology that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

An Engineering Specialist of Device Development and Technology is a key member of our company's Research Laboratories to our company with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally.

Experience in design controls, device risk management, medical device, combination products, glass/plastic prefilled syringes, pharmaceutical packaging and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Engineering Specialist will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.

This individual will be expected to function as an independent contributor, supporting global and site specific projects, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners.

The key stakeholders include our Company Manufacturing Division sites, External manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement and suppliers.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Complete all activities with the highest regard for all of our Company divisional and local site procedures for safety, quality, and regulatory compliance

• Understand the big picture, and how activities link to our Company strategy and business goals

• Utilize device risk management tools to build device or combination product risk management programs in development and life cycle management

• Utilize design control experience to develop value-add solutions to customer needs in medical devices and combination products

• Secure early sponsorship and stakeholder alignment for projects and initiatives.

• Operate effectively as a leader in assigned roles

• Demonstrate the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to key stakeholders and sponsors

• Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations

• Lead technical investigations of medical device and combination product needs for commercial products

• Facilitate technology transfer of medical device and combination products from development to commercialization

This job posting covers opportunities within Device Technology Operations under the Technology Transfer and Device Product Stewardship groups supporting commercialization and lifecycle management of combination products. We are actively looking for highly motivated people with a passion for innovation and interest in contributing to one or more of the technical functional areas mentioned above.

Education

• Required | Technical BS degree or higher  

• Preferred | BS in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, Pharmaceutical Sciences or similar   

Experience | Skills | Knowledge

Required

• Three years of relevant experience

• Experience in working with cross-function team

• Experience in authoring design controls, technical assessment , device risk management file m and/or design verification reports the Experience with design of medical device or combination product commercialization, operations support, and materials/components

• Proficiency in project management

• Principled verbal and written communications

Preferred

• Three plus years in medical device, pharmaceutical or in biotech organizations

• Three plus years in design control, risk analysis and change control management for medical device or combination products

• Provides technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents

• Experience in commercialization of high volume medical device or combination products

• Knowledge of sterile and non-sterile combination products

• Experience with Drug Delivery Systems

• Lean Six Sigma Green Belt or higher certification

#eligibleforERP

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 listedhere.

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:

Regular

Relocation: