Benefits:
401(k)
Competitive salary
Dental insurance
Health insurance
Paid time off
Vision insurance
Wellness resources
Position Summary
We are seeking a highly motivated Mechanical Engineer / Project Engineer with 5+ years of professional engineering experience and strong 3D CAD design expertise to support the development, implementation, and continuous improvement of advanced biodecontamination systems and equipment. The ideal candidate will possess a blend of mechanical design, product development, and project management skills, with experience in regulated industries such as pharmaceutical, biotechnology, healthcare, medical device, cleanroom, or contamination control environments.
This role is responsible for leading projects from concept through manufacturing and customer deployment while ensuring products meet performance, quality, regulatory, and customer requirements. The successful candidate will work closely with cross-functional teams to deliver innovative, reliable, and cost-effective biodecontamination solutions. This position will require up to 25% travel.
Key Responsibilities
Mechanical Engineering & Product Development
Design and develop mechanical components, assemblies, and systems for biodecontamination equipment and related technologies.
Create and maintain detailed 3D models, assemblies, manufacturing drawings, and bills of materials (BOMs) using CAD software such as SolidWorks, Creo, or Autodesk Inventor.
Support the full product development lifecycle from concept generation through prototype development, testing, manufacturing, and product launch.
Perform engineering calculations, tolerance stack-up analyses, material selection, and design verification activities.
Develop and maintain engineering documentation including specifications, test protocols, validation reports, user manuals, and design records.
Conduct root cause investigations and implement corrective actions for product, manufacturing, and field issues.
Collaborate with manufacturing teams to improve product quality, reliability, manufacturability, and cost efficiency.
Participate in design reviews, risk assessments, FMEA activities, and engineering change management processes.
Ensure designs comply with applicable safety, quality, and regulatory requirements.
Project Management & Leadership
Lead engineering projects from concept through design, manufacturing, validation, and customer deployment.
Develop project schedules, budgets, resource plans, and technical deliverables.
Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Supply Chain, Service, Sales, and Regulatory Affairs.
Track project progress and communicate status, milestones, risks, and mitigation plans to management and stakeholders.
Manage engineering change requests and ensure project objectives are achieved on schedule and within budget.
Lead customer technical discussions, project reviews, and design meetings.
Support installation, commissioning, and startup activities when required.
Drive continuous improvement initiatives utilizing project management best practices and lessons learned.
Required Qualifications
Bachelor's Degree in Mechanical Engineering or a related engineering discipline.
Minimum 5 years of mechanical engineering and product development experience.
Minimum 3 years of experience with and strong proficiency in 3D CAD software (SolidWorks preferred, Creo, Inventor, or equivalent).
Demonstrated experience managing engineering projects, timelines, budgets, and deliverables.
Strong knowledge of mechanical design principles, materials, manufacturing processes, and assembly methods.
Experience creating detailed manufacturing drawings and documentation.
Knowledge of GD&T, tolerance analysis, and engineering calculations.
Experience with engineering change management and product lifecycle management processes.
Strong analytical, problem-solving, and troubleshooting skills.
Excellent written, verbal, and presentation communication skills.
Proven ability to work independently and effectively within cross-functional teams.
Preferred Qualifications
Experience in the biodecontamination, pharmaceutical, biotechnology, medical device, life sciences, cleanroom, or contamination control industries.
Experience with Vaporized Hydrogen Peroxide (VHP), sterilization systems, isolation technology, environmental control systems, or decontamination equipment.
Familiarity with GMP, ISO, ASME, CE, and other applicable industry standards.
Experience designing electro-mechanical systems, sheet metal components, machined parts, and fabricated assemblies.
Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) methodologies.
Formal project management training or certification (PMP, CAPM, or equivalent) a plus.
Experience supporting customer-facing projects in regulated environments.
Technical Skills
3D CAD Modeling and Design
Mechanical System Design
Product Development
GD&T and Tolerance Analysis
Engineering Drawings and Documentation
Root Cause Analysis
FMEA and Risk Assessments
Design for Manufacturing (DFM)
Design for Assembly (DFA)
BOM Management
Prototype Testing and Validation
Engineering Change Management
Project Planning and Scheduling
Budget and Resource Management
Risk Assessment and Mitigation
Cross-Functional Team Leadership
Desired Competencies
Excellent leadership and team collaboration abilities.
Ability to manage multiple concurrent projects in a fast-paced environment.
Results-oriented with a focus on quality, customer satisfaction, and continuous improvement.
Strong attention to detail while maintaining a strategic perspective.
Effective decision-making and problem-solving capabilities.
Ability to communicate technical concepts to both technical and non-technical audiences.
Self-motivated, proactive, and capable of driving projects to successful completion.
Strong project management and organizational skills.