Lead Mechanical Engineer – Pharma Equipment

ATS Scientific Products; Warminster Township (Bucks County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) including company match

Paid Time Off annually + Paid Holidays

Career advancement opportunities andtu

Tuition assistance

Job summary

SP Industries, Inc. is seeking a Mechanical Engineer to drive design, development, and optimization of pharmaceutical equipment. Lead multidisciplinary teams and apply advanced engineering to deliver high-performance, compliant solutions.

The ideal candidate has 5+ years in pharma/medical device design, CAD/CAE proficiency, and strong knowledge of FDA cGMP and ISO 13485 standards. This role emphasizes collaboration, problem solving, and continuous improvement.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field; advanced degree preferred.
• Minimum of 5 years in mechanical engineering roles within pharmaceutical or medical device industry, with a focus on equipment design and development.
• Proficiency in CAD software (SolidWorks, AutoCAD) and engineering simulation tools (ANSYS, COMSOL).
• Strong understanding of regulatory requirements (FDA cGMP, ISO 13485, ASME BPE).
• Experience leading multidisciplinary engineering teams and driving projects from conception to completion.

Responsibilities

• Lead design and development of mechanical components and systems for pharmaceutical equipment, from concept to production.
• Conduct structural, thermal, and fluid dynamics simulations to optimize performance and ensure regulatory compliance.
• Collaborate with R&D, manufacturing, QA, and regulatory affairs to integrate systems into products.
• Drive continuous improvement to enhance reliability, manufacturability, and cost-effectiveness.
• Mentor junior engineers and support testing, validation, and on-site troubleshooting.

Skills

Regulatory compliance

Cross-functional collaboration

Leadership

Problem solving

Communication

Education

Bachelor's degree in Mechanical Engineering

Advanced degree preferred

Tools

SolidWorks

AutoCAD

ANSYS

COMSOL

Job description

SP Industries, Inc. is seeking a Mechanical Engineer to drive design, development, and optimization of pharmaceutical equipment. Lead multidisciplinary teams and apply advanced engineering to deliver high-performance, compliant solutions.

The ideal candidate has 5+ years in pharma/medical device design, CAD/CAE proficiency, and strong knowledge of FDA cGMP and ISO 13485 standards. This role emphasizes collaboration, problem solving, and continuous improvement.