Specialist, Drug/Device Combo Products (Hybrid)
Specialist, Drug/Device Combo Products (Hybrid)
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$ 85600 - 134800
1 Vacancy
Job Description
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 highperforming 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 companys 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 fastpaced 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 stakeholders 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 problemsolving 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 valueadd 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
Three years of relevant experience
Experience in working with crossfunction 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 nonsterile 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 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:
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 anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$85600.00 $134800.00Available 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/16/2025*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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
