Senior Engineer, Device Automation and Process Development (Hybrid)

Job Description

As a Senior Engineer in Device Design and Process Development group, you will be part of our R&D team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for drug delivery systems. Reporting to the Director responsible for this area, you will partake in device assembly and process development using semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as equipment SME, assist with FAT, SAT, installation/qualification of equipment at our manufacturing sites, interrogation of subassembly processes at our device supplier sites, and provide hands-on troubleshooting to operations as needed.

Key Responsibilities:

• Understand product design, functionality, storage, and handling requirements to develop robust equipment and processes for clinical and commercial manufacture of drug-device combination products.

• Understanding of parenteral delivery device design and function, and the ability to develop robust assembly specifications with sound justification.

• Gain fundamental understanding of existing assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.

• Familiarity with assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.

• Develop characterization plans and prototype small-scale equipment to prove out concepts prior to implementation.

• Conduct testing using tensile tester or other laboratory equipment and analyze data to inform process development activities.

• Assist clinical manufacturing team with authoring relevant SOPs and specifications to enable clinical batch manufacture.

• Hands on troubleshooting in a manufacturing environment with an ability to operate assembly equipment and/or assist clinical manufacturing team with batch manufacturing.

• Interface with key stakeholders within the design team, molding team, design verification team, device technical operations, and manufacturing sites.

• Travel to OEMs to review equipment design, conduct line trials including FAT and report project progress, risks, and mitigations to the team.

• Author process FMEA to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.

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

• Identify and implement process improvements by working collaboratively with device technical operations and manufacturing sites on existing and new equipment.

Education qualifications:

• A Bachelors or Masters degree in Mechanical Engineering with 5 years of work experience

Required:

• Experience in the design and development of assembly equipment and processes.

• Strong problem-solving and technical writing skills.

• Proficient in computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD etc

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

• 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.

• Prior experience in glass container handling/assembly and complex medical device manufacturing (molding and assembly) is preferred but not required.

Preferred:

• Experience in machining, prototyping and 3D printing

• Rudimentary understanding of automation controls and wiring diagrams

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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: