Device and Clinical Package Design Engineer (Hybrid)

Job Description

As a Device and Clinical Package Design Engineer, you will be part of our R&D team that develops drug delivery systems and designs secondary packaging for combination products in clinical space.

Key Responsibilities:

• Demonstrates working knowledge of combination product devices.

• Experienced in the design, development, and performance testing of secondary packaging for combination products with demonstrated experience operating packaging CAD programs (Solidworks and Artios) to design machinable, sustainable packaging solutions with deliverable solutions which perform in distribution testing.

• Designs, prototypes, conducts testing and analyzes data to inform design development activities.

• Has experience in design verification specifically focused on package distribution testing for combination products

• Can specify standards for packaging materials not limited to paperboard and corrugate as well as packaging equipment for label application, carton and blister forming.

• Can generate drawings and specifications (design outputs) to be captured in Design History File.

• Collaborate with systems engineering team to develop robust set of design input requirements based on user needs and target product profile.

• Apply DFM/DFA principles to interrogate sourced device and packaging components or design bespoke device or packaging components.

• Develop test plans to understand design space and to ensure device and packaging technology is adequately suited for the combination product.

• Conduct or analyze tolerance stack ups utilizing worst-case and statistical methods such as RSS or Monte-Carlo simulation.

• Identify critical to function/safety and critical to process dimensions and ensure adequate controls exist to maintain device performance within acceptable range.

• Interface with key stakeholders in cross-functional development teams and provide technical insight and leadership on the device design aspects of the development program.

• Travel to OEMs/Suppliers to review product design, functional data, manufacturing processes and conduct due diligence on robustness of their product and process.

• Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.

• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.

• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.

• Understand Process validation activities like IQ, OQ, PPQ etc. Review and approve Process validation documentation.

Education qualifications:

• Bachelor’s Degree in Mechanical Engineering, Packaging Engineering, or related fields with a minimum of 2 years of design, packaging and mechanical/distribution testing experience.

Required:

• Proficient in creating solid models, assemblies etc. using computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD, ArtiosCAD etc.

• Proficient in creating and reviewing detailed engineering drawings, applying basic GD&T principles for dimensioning and tolerancing.

• Knowledge of standards (ASTM/ISTA) for evaluation and qualification of packaging systems.

• Ability to perform modeling and structural design of secondary packaging with output for prototyping in multiple materials including paper.

• Strong problem-solving, analytical, technical writing and presentation skills with high level of proficiency in utilizing MS Office Suite

• Ability to analyze data using statistical software such as Minitab.

• Hands on experience in developing test methods and fixtures for tensile tester, conducting method feasibility, Gauge R&R evaluation, and method validation.

• Excellent collaborative and communication skills, with a proven ability to work effectively with cross-functional teams and external partners to achieve strategic business goals.

Preferred:

• Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus.

• Experience in the design and development of drug delivery systems such as prefilled syringes and autoinjectors.

• Experience in machining, prototyping and 3D printing.

ElligibleforERP

AR&D

Required Skills:

ArtiosCAD, Clinical Supply Chain Management, Collaborative Communications, Combination Products, Computer-Aided Design (CAD), Computer-Aided Design And Drafting (CADD), Cross-Functional Planning, Data Analysis, Drug Delivery, Interpersonal Relationships, Mechanical Engineering, Medical Devices, Medical Product Development, Packaging, Product Packaging Design, Risk Management, Self Motivation, SolidWorks

Preferred Skills:

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.

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 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 salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.