Position Summary:

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 Design & Development
. Architect subsystem changes (enclosure/chassis, mechanisms, thermal/fluidics/optical interfaces).
. Conduct advanced analyses (FEA-lite, thermal modeling, fluidic characterization).
. Define reliability test plans (ALT/HALT, life testing) own acceptance criteria.

Manufacturing Support & NPI
. Lead readiness for mass production: PFMEA updates, process controls, test method validation (TMV).
. Approve critical fixture design changes ensure calibration strategies.

Quality, Reliability & Data
. Institutionalize SPC dashboards and paretos own CTQ monitoring.
. Lead troubleshooting using structured frameworks (8D, KT) with statistical validation.
. Define CTQs and monitor Cp/Cpk for critical features.
. Mentor juniors on interpreting SPC and DOE outputs.
. Frames decisions with confidence intervals and risk quantification.
. Coaches team to replace gut feel with evidence.
. Escalates issues with quantified impact (yield %, cost). Project & Process
. Create and maintain integrated schedules present status/risks at core team.
. Manage cross-functional action logs drive risk registers (severity × occurrence × detectability).

Documentation & Compliance
. Author/approve validation protocols and reports ensure full traceability.
. Ensure change control rigor (ECR, deviations, waivers) audit readiness.

Collaboration
. Coordinate design engineering and operations harmonize requirements with service feedback.
. Travel to CM/supplier sites for first builds lead lessons learned.

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 5 years of related experience with a Bachelor's degree or 3 years and a Master's degree or a PhD without experience or equivalent work experience.

. Deep expertise in mechanical mechanisms, GD&T, tolerance analysis and DFMA principles.
. Strong understanding of thermodynamics and heat-transfer fundamentals.
. Familiarity with optics and fluidics interface considerations in complex systems.
. Advanced proficiency in CAD and PLM systems.
. Skilled in data analytics tools such as Excel, Minitab and JMP scripting experience (e.g., VBA/Python) is a plus.
. Familiarity with ISO 13485, IEC 61010 and design control frameworks.
. Proven ability to mentor and guide junior engineers on technical approaches and best practices.
. Strong ability to communicate technical information clearly, concisely, and in a stakeholder-oriented manner.
. Proven capability to anticipate manufacturability challenges and design for robustness and reliability.
. Proven ability to evaluate technical trade-offs (COGS, quality, schedule) using data-driven decision-making.
. Experience coaching engineers on analysis depth, documentation quality, and disciplined execution.

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

Senior Product Engineer (Mechanical)