Position Summary:

This role is responsible for supporting product lifecycle activities, including new product introduction, product transfer, and ongoing manufacturing operations. This role ensures product quality, yield, and compliance through engineering evaluation, troubleshooting, and continuous improvement initiatives. Collaborates cross-functionally to drive process enhancements, cost optimization, and operational excellence, enabling smooth transition from design to production and sustaining high-performance standards throughout the product lifecycle.

Position Responsibilities:

Common Responsibilities:

Support and drive product transfer into manufacturing.
Perform data trending and analysis.
Apply FMEA, DOE, and statistical analysis to optimize product quality and reduce costs.
Drive process improvements, cost reduction, and product sustaining activities.
Manage Engineering Change Request and Notifications (CRs and CNs), including updates to work instructions and test requirements.
Support documentation: engineering drawings, BOMs, test reports, assembly procedures, and validation plans.
Participate in continuous improvement initiatives and operational excellence programs.
Frequent cross-functional collaboration and occasional travel to other sites.
Provide guidance and mentorship to junior staff.

Discipline-Specific Responsibilities:

Mechanical Engineering

Strategy & Architecture

Set long-term technical roadmaps guide platform interfaces (mechanical/thermal/fluidics/precision motion/structure/electro‑mechanical).
Approve critical architecture decisions define reliability targets.

Standards & Governance

Establish/own global design standards, verification/validation frameworks, and change control policies, drive compliance maturity.
Sponsor cross-site technical councils and knowledge systems.

Innovation & Technology

Identify enabling technologies lead feasibility and pilot integrations (e.g., advanced thermal management, precision mechanisms, smart fixtures, reliability engineering.

Enterprise Impact

Orchestrate multi-program cost/quality roadmaps balance portfolio-level trade-offs.
Advise executives provide decision memos with quantified risk/benefit.

Quality, Reliability & Data

Define enterprise standards for data-driven decision-making.
Sponsor predictive analytics and AI-driven insights for reliability and cost.
Mentor leaders on statistical thinking and evidence-based governance.
Consistently validates strategic decisions with robust data models.
Sets cultural expectation: No data, no decision.
Coaches directors and managers on interpreting analytics for portfolio decisions.

Mentorship & Talent

Coach staff/senior engineers elevate technical career paths define competency matrix and training.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

Typically requires a minimum of 12 years of related experience with a Bachelor's Degree or 8 years and a Master's Degree or a PhD with 5 years experience or equivalent experience.
Deep expertise in thermodynamics, heat transfer, vibration, stress analysis and mechanical system behavior.
Able to set modeling and analysis standards and review complex FEA and thermal studies.
Advanced understanding of machining and manufacturing processes, with proven DFM/A leadership for plastics, sheet metal, castings and precision mechanisms.
Proficient in SolidWorks or equivalent CAD tools, and capable of establishing modeling and drafting conventions and drawing-release quality expectations.
Strong command of GD&T, DFMA, FMEA, DOE and statistical methodologies, and able to mentor teams on tolerance stacks and risk-based decision making.
Familiar with BOM structuring, ECR creation and enterprise-scale change control processes, ensuring cross-product impacts are assessed.
Working knowledge of electronics and lab test equipment to support electro-mechanical, optical and fluidic integration.
Experienced in Excel, MS Project and LabView, with scripting capability (Visual Basic, Python, JMP) considered an advantage.
Preferably experienced in FDA-regulated industries, including life sciences, biotech and medical device environments, with knowledge of ISO 13485 and ISO 14971.
Provides strong technical leadership and clear communication across multiple functions and stakeholder groups.
Operates independently at enterprise scope, influencing global sites and supplier/CM networks.
Able to navigate changing priorities effectively while maintaining resilience and sound judgment.

All listed requirements are deemed as essential functions to this position however, business conditions may require reasonable accommodation for additional task and responsibilities.

Senior Staff Product Engineer (Mechanical)