Associate Principal Engineer, Drug-Device Combination Products

Education: Minimum Requirement: B.S. Degree in Mechanical Engineering or related field with a minimum 15 years of regulated industry experience Required skills and key responsibilities for this position include: Can develop detailed plans and strategies for combination of product assembly process and equipment development and lead technical team to deliver a qualified process and equipment for clinical or commercial use Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality. Design and author Process validation activity and documentation like IQ, OQ, PPQ etc. Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs. Experience in designing automated combination product assembly equipment and experience in managing equipment suppliers Experience in developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems Experience and the ability to manage all aspects of manufacturing site readiness including equipment qualification requirements and all associated documentation Understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes Excellent oral and written communication skills and the ability to present complex information in a clear and concise manner to partner group stakeholders Mechanical aptitude and hands-on troubleshooting skills, with the ability to work independently in a laboratory setting and manufacturing floor setting. Strong interpersonal skills with an ability to collaborate in a team environment High level work ethic Support process and technology transfer to our company's manufacturing facilities

Preferred Experience and Skills: CAD design, including knowledge of SOLIDWORKS and3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing#EligibleforERP

Required Skills: Assembly Language (ASM), Assembly Language (ASM), Assembly Processes, CAPA Management, Combination Products, Component Development, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design for Assembly (DFA), Design for Manufacturing (DFM), Design Verification Testing, Device Design, Diversity Awareness, Documentation Preparation, Engineering Document Management, Engineering Support, Equipment Designing, Equipment Engineering, Fixtures Design, Human Factor Engineering, Manufacturing Strategies, Mechanical Testing, Medical Device Manufacturing, Medical Device Quality Systems {+ 9 more}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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: EEOC Know Your RightsEEOC GINA Supplement 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 ActsThe salary range for this role is$142,400.00 - $224,100.00 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 .You can apply for this role through (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: DomesticVISA Sponsorship: NoTravel Requirements:10%Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Location: USA - New Jersey - Rahway

Type: Full time