Senior Engineer, Device Automation and Process Development (Hybrid)
Senior Engineer, Device Automation and Process Development (Hybrid)
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$ 114700 - 180500
1 Vacancy
Job Description
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/lowvolume to highvolume 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 semiautomated 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 handson 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 drugdevice 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 smallscale 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 inprocess 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 problemsolving and technical writing skills.
Proficient in computeraided design (CAD) and computeraided engineering (CAE) software such as SolidWorks AutoCAD etc
Excellent collaborative and communication skills with a proven ability to work effectively with crossfunctional 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:
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:
$114700.00 $180500.00Available 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:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
exposure to some drug productsJob Posting End Date:
05/13/2025*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:
Senior IC
Employment Type
Full-Time
