Requisition ID: TOO000100
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Engineer within the Device Development organization enables the development of Medical Devices and Combination products for a wide range of Drug Product dose presentations, including parenteral, (e.g. syringes and auto-injector pens), inhalation and nasal sprays. Device Development engineering assignments include: computer aided design (CAD), analysis, and rapid prototyping (e.g. 3D Printing) of Medical Devices through concept and design phases; implementation of lead prototypes using injection mold tooling; verification of design through finite element analysis (FEA) and/or mechanical testing; and, finally, transfer and validation of Device Design for commercial manufacture. The Engineer will support pipeline products and standalone medical devices designs.
Key Responsibilities and Primary Activities:
• Identify, develop, and validate innovative design evaluation and verification methods.
• Design and prototype medical device and combination products using state of the art tools including CAD, FEA, and 3D Printing.
• Work on interdisciplinary teams to advance the development of combination products.
• Work with second and third-party suppliers and vendor.
• Apply scientific and engineering expertise and research experience to solve problems creatively and independently.
• Drive in-vitro evaluations of Device Design for combination products and formulations.
• Identify, evaluate and recommend new Device technology and instrumentation for the department.
• Document results in electronic notebooks and formal reports/memos as needed.
• Communicate findings and interpret results to key stakeholders via written reports and presentations.
• Contribute to development milestone reports and/or filing documents.
• Collaborate fluently with discovery and manufacturing colleagues.
• May present to senior management, worldwide teams or external audiences.
• Maintain established scientific and engineering excellence and commitment to innovation.
• May lead and implement departmental and inter-departmental initiatives (e.g. new technology, improved collaborations between different departments, development and implementation of new business processes, etc.).
• Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Additional activities may be assigned by the manager/supervisor.
Education Minimum Requirement: B.S. or M.S. in Mechanical Engineering, Biomechanical Engineering, Materials Science and Engineering, Electrical Engineering, Packaging Engineering or equivalent field is required 5 years minimum
Required Experience and Skills:
• Ability to perform statistical analysis on data obtained from feasibility studies and formal verification.
• Utilize engineering tools (e.g., Design of Experiments, MATLAB, Solidworks, AutoCAD etc.) to solve problems.
• Create, and review engineering test protocols and reports in support of design verification, design validation, and process validation
• Expertise in creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation
• Drive Verification strategies for new product development
• Drive Verification and Validation strategies for new product development
• Work with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.
• Establish experimental protocols, conduct experiments, analyze results
• Develop and execute product test plans ranging from early bench testing/prototype evaluation to final validation and verification.
• Generate design controls, risk management documentation, and other technical memos, conducting root cause and engineering analyses as necessary.
• Excellent communication skills
• Fluency in state of the art Computer Aided Design (CAD) software
• Experience with rapid prototyping techniques like 3D printing
Preferred Experience and Skills:
- Fluency in state of the art Finite Element Analysis (FEA) software
-- Familiarity with pharmaceutical development
- Familiarity with Industry Related Knowledge
• 21 CFR Part 4
• 21 CFR 820
• 21 CFR 211
• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics
• ISO 13485
• ISO 14971
• ISO 11608
• ISO 11040
• ISO 10993
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Tool and Design Engineering
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark