Sr Product Process and Design Engineer (Instrument Mfg)

Job Description

Job Description

Summary of company: This role is for our sister company - Mainline Scientific is a Malvern, Pennsylvania-based bioanalytical technology company, focusing on developing and manufacturing robust and innovative life science instrumentations.

Title: Sr Manufacturing Engineer

Department: Manufacturing

Location: Malvern, PA

Supervisory Responsibility: No

FLSA Status: Exempt

Position Type: Full - time

Travel Required: Yes, occasionally

Expected Hours of Work: 40 hours a week M-F 9-5 in office

Summary/Objective

We are seeking a skilled and motivated Sr Manufacturing Engineer to join our team in supporting the production of advanced analytical instruments. In this role, you will work closely with R&D engineers to bridge product design and manufacturing, playing a key role in process development, production line setup, and continuous improvement initiatives. This position is ideal for someone who is hands-on, detail-oriented, and passionate about quality, efficiency, and innovation in manufacturing.

Description

Essential Duties and Responsibilities

• Collaborate with R&D engineers to design and develop scalable and robust manufacturing processes.
• Design, establish, and optimize production lines for new and existing analytical instruments.
• Develop and implement product packaging solutions to ensure protection, compliance, and efficient logistics.
• Lead the qualification and validation of manufacturing processes to meet regulatory and quality standards.
• Plan, coordinate, and support product builds, from prototyping through to full-scale production.
• Monitor and drive improvements in production yield, efficiency, and product quality.
• Identify and implement continuous improvements in products and processes for enhanced quality, reduced cost, and improved delivery performance.

Requirements

Qualifications Requirements

• ~2+ years of relevant experience in manufacturing engineering, preferably in the instrumentation or high-tech equipment sector.
• Strong problem-solving skills with a hands-on approach to engineering challenges.
• Familiar with ISO9001 QMS
• Experience with production line setup, process qualification, and continuous improvement tools (e.g., Lean, Six Sigma) is a plus.
• Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.

Preferred Skills:

• Familiar with ISO13485 or 21CFR820 Quality Management System for Medical Device
• Prior design or development experience for analytical instruments or medical devices.
• Hands-on experience in prototyping, soldering, and debugging

Education, License, Certification, or Preferred Qualifications

• Bachelor’s degree in Engineering or a related STEM discipline (e.g., Mechanical, Electrical, Industrial, or Manufacturing Engineering).

Tools and Technology Used

• Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook…)

Work Environment & Mental and Physical Requirements

• Ability to remain in a stationary position; move; operate and use required equipment; and reach items.
• Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally.
• Ability to communicate, converse with others, and exchange information

Benefits

Medical (HMO + PPO), Dental, Vision, & employer-paid Basic Life/AD&D + ST Disability

4% Match 401k

PTO: 15 days (vacation/personal days) + 5 sick days + holidays