Senior Staff Engineer, Hardware

Position Overview

In this role, you will be responsible for resolving production process issues through strong, structured problem‑solving. You will serve as the mechanical technical owner for consumable assemblies and interfaces, ensuring reliable, scalable, and cost‑effective production performance.

You will also drive design controls excellence, materials and process selection, manufacturing readiness, and sustaining engineering support across the product lifecycle.

Key Responsibilities

Production Issue Resolution

• Identify root causes using structured problem‑solving methods
• Develop and implement effective, sustainable solutions

Technical Ownership – Consumable Mechanical Subsystems

• Own mechanical design performance for consumable assemblies
• Ensure production reliability, manufacturability, scalability, and cost efficiency

Design Controls

• Create and maintain design inputs and outputs
• Develop DHF documentation, DFMEA / PFMEA, verification evidence, and change records
• Ensure compliance with Werfen QMS and relevant standards

Manufacturing Readiness

• Drive DFM / DFA strategy and tooling plans
• Partner with Operations and suppliers to scale high‑volume manufacturing
• Establish robust process windows and readiness criteria

Materials and Process Selection

• Select and validate materials (polymers, films, adhesives, seals)
• Support processes including welding, bonding, and sealing

Verification and Test Methods

• Define verification strategies
• Create test methods, fixtures, gaging strategies, and analysis plans
• Support traceable verification and documentation

Lifecycle and Sustaining Engineering

• Lead investigations for field and manufacturing issues
• Support CAPA, design updates, and cross functional improvements
• Implement effective corrective and preventive measures

Continuous Improvement

• Lead or participate in Lean Six Sigma projects of significant scope

Qualifications

Technical Skills

• Strong engineering fundamentals:
• injection molding, plastic welding, precision mechanical design, tolerance analysis, GD&T, materials selection, failure analysis
• Deep experience with DFM / DFA for high volume production
• Skilled in automation, tooling strategy, and manufacturing ramp support
• Proven ability to translate requirements into robust design solutions
• Structured root‑cause problem solving and statistical thinking
• Clear documentation and communication expertise
• Proficiency in modern engineering tools:
• AI enabled tools, 3D CAD, PDM / PLM, measurement methods
• (FEA is a plus)

Experience

• Bachelor’s degree in Mechanical Engineering or related field
• (MS or higher preferred)
• 10 years of progressive mechanical engineering experience
• Experience owning subsystem or product scope through V&V and design transfer
• Medical device or regulated industry experience strongly preferred
• Consumables manufacturing experience highly desired:
• injection molding, lamination, sealing, ultrasonic / thermal welding, adhesives, precision assembly
• Familiarity with ISO 13485, 21 CFR 820, ISO 14971
• Lean or Six Sigma experience preferred

Job Type & Location

This is a Permanent position based out of San Diego, CA.

The pay range for this position is $175000.00 - $210000.00/yr.

Full benefits available: medical, dental, 401K, etc

This is a fully onsite position in San Diego,CA.

This position is anticipated to close on Mar 5, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $175,000 - $210,000