Mechanical Engineer

Overview (W2 Contract)

We are seeking a highly skilled
Mechanical LCM Engineer
to support advanced patient monitoring systems within a leading global medical technology organization (company name confidential). This role is an exciting opportunity to collaborate across manufacturing, engineering, and operations teams to drive process excellence, product improvements, and high-quality commercialization efforts.

You will play a key role in executing manufacturing strategy, supporting ongoing production, enabling new product launches, managing supplier and part changes, and leading continuous improvement initiatives.

Key Responsibilities

Manufacturing & Process Optimization

• Identify, recommend, and implement opportunities to optimize manufacturing processes using engineering methodologies (Lean, Six Sigma, DOE, etc.).
• Redesign or develop parts, tools, equipment, and fixtures to meet quality and performance standards.
• Use data analysis and problem-solving skills to support and troubleshoot issues with contract manufacturers.

Project & Operational Support

• Lead and support initiatives such as material qualifications, supplier/label/part changes, product enhancements, tolerance stack analysis, and equipment qualifications.
• Support key project initiatives including supplier transfers, line extensions, cost-reduction programs, quality improvements, and system enhancements.
• Manage engineering change control activities (CAD updates, change requests, process changes, product specs, DMR updates, test processes, service processes).

Product Change Notification (PCN) Management

• Review incoming PCNs for material, mechanical, electrical, and datasheet changes.
• Route relevant changes to product owners and maintain a tracking system for review, routing, and approvals.
• Collaborate with cross-functional teams to refine PCN triage criteria and drive efficiency.

Technical Execution & Validation

• Develop and execute complex experiments, qualification plans, and validation protocols.
• Analyze results, prepare reports, and make recommendations for improvements.
• Resolve complex manufacturing and compliance issues (CAPA, NCs, audit observations).
• Develop technical documentation and work instructions to support knowledge transfer to production teams.

Leadership & Collaboration

• Lead project planning efforts using tools such as risk analyses and project timelines.
• Partner closely with internal teams and suppliers, including representing the organization on significant cross-functional or supplier-driven initiatives.

Education & Experience Requirements

Required:

• Bachelor's degree in Engineering or a Scientific field with
  5+ years
  of relevant experience,
  OR
• Master's degree in Engineering or a Scientific field with
  4+ years
  of experience,
  OR
• PhD in Engineering or a Scientific field with relevant industry experience.

Required Skills

• Proficiency in MS Office and MS Project.
• Experience with PLM systems —
  Windchill required
  , Teamcenter preferred.
• Mechanical CAD proficiency (SolidWorks, CREO, ProE).
• Strong documentation, communication, and interpersonal skills.
• Basic understanding of statistical analysis methods.
• Experience working with lab or industrial equipment.
• Solid understanding of engineering principles, process excellence practices, and manufacturing equipment.
• Strong organizational, analytical, and problem-solving skills.
• Ability to influence change and lead cross-functional efforts.
• Knowledge of FDA medical device regulations preferred.
• Exceptional attention to detail and ability to manage competing priorities in fast-paced environments.
• Ability to work effectively with all levels of the organization, including senior leadership and external partners.
• Commitment to safety, compliance, and company protocols.

Preferred Qualifications

• Familiarity with medical device regulatory frameworks (ISO 13485, CFR 820, etc.).
• Lean or Six Sigma Certifications (Green Belt, Black Belt, or Lean Champion).
• Ability to read electronic schematics and mechanical drawings.
• Experience troubleshooting device and component-level failures and documenting evaluations.