Sr. Mechanical Engineer

Katalyst CRO; Rahway (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Join a leading company in the pharmaceutical manufacturing sector as a Sr. Mechanical Engineer. You will be responsible for applying your expertise in mechanical design and analysis to develop innovative solutions while leading projects and mentoring junior engineers. This role in New Jersey offers a competitive salary and the opportunity to contribute to the development of compliant and effective medical devices.

Qualifications

• Minimum of 10 years of experience in mechanical design and product development.
• Proficient in SolidWorks and CAD tools with formal training preferred.
• Experience with FDA, IEC, and UL standards for medical equipment.

Responsibilities

• Apply mechanical design and analysis for complex projects.
• Collaborate with engineering teams during the design process.
• Conduct testing to verify compliance with safety and performance.

Skills

Design for Manufacturability and Assembly principles

Analytical reasoning

Creative problem-solving

Interpersonal skills

Communication skills

Education

BSME or MSME

Tools

SolidWorks

MCAD

Microsoft Office Suite

Job description

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• Apply subject matter expertise in mechanical design, analysis, and system development.
• Conceive and develop solutions to complex analytical, pneumatic, mechanical, and electrical design challenges.
• Establish design objectives and contribute to writing specifications and comprehensive engineering reports.
• Participate in the review and development of detailed product specifications.
• Conduct conceptual and detailed design studies using MCAD, Solidworks, and other tools.
• Collaborate with multidisciplinary engineering teams throughout the design and development process.
• Develop prototype hardware in coordination with internal manufacturing and external vendors.
• Conduct rigorous testing to verify compliance with performance, safety, regulatory, and environmental requirements.
• Generate and maintain detailed engineering documentation to support the product development lifecycle.
• Serve as a technical mentor and project lead, providing guidance and support to junior engineers and managing small to medium-sized projects.
  
  

Responsibilities

• Apply subject matter expertise in mechanical design, analysis, and system development.
• Conceive and develop solutions to complex analytical, pneumatic, mechanical, and electrical design challenges.
• Establish design objectives and contribute to writing specifications and comprehensive engineering reports.
• Participate in the review and development of detailed product specifications.
• Conduct conceptual and detailed design studies using MCAD, Solidworks, and other tools.
• Collaborate with multidisciplinary engineering teams throughout the design and development process.
• Develop prototype hardware in coordination with internal manufacturing and external vendors.
• Conduct rigorous testing to verify compliance with performance, safety, regulatory, and environmental requirements.
• Generate and maintain detailed engineering documentation to support the product development lifecycle.
• Serve as a technical mentor and project lead, providing guidance and support to junior engineers and managing small to medium-sized projects.
  
  

Requirements:

• Expertise in Design for Manufacturability and Assembly (DFM&A) principles.
• Proficient in SolidWorks CAD software; formal training preferred.
• Strong background in materials and manufacturing methods including:
• Injection moulding.
• Plastic extrusion.
• Metal casting, stamping, and machining.
• Additive manufacturing.
• Familiarity with ANSI/ISO dimensioning and drafting standards and GD&T.
• Experience with mechanical testing and measurement equipment, and statistical analysis of test data.
• Understanding of regulatory requirements and document control systems (especially within medical device environments).
• Experience in applying FDA, IEC, and UL standards for medical electronic equipment.
• Capable of thermal, structural, and vibration analysis.
• Demonstrated skill in mechanism design, analytical reasoning, and creative problem-solving.
• Strong interpersonal, verbal, and written communication skills.
• Ability to operate lab and shop equipment (e.g., drill press, lathe, milling machine, oscilloscopes, DVMs, environmental chambers).
• BSME or MSME required.
• Minimum of 10 years of progressive experience in mechanical design and product development.
• Proven experience leading technical sub-projects and mentoring engineers.
• Advanced proficiency with: SolidWorks, MCAD/CAE tools, Microsoft Office Suite, Microsoft Visio and Project, Adobe Acrobat.
• Experience with database and document management systems.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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