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Manufacturing Engineer

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: Manufacturing Engineer

Department: Manufacturing

Report to (title): Manufacturing Manager

Location: Malvern, PA

Supervisory Responsibility: No

FLSA Status: Exempt

Position Type: Full Time

Travel Required: Yes, occassionally

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

Summary/Objective

We are seeking a skilled and motivated 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.

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

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

Average salary estimate

$82500 / YEARLY (est.)
min
max
$70000K
$95000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Manufacturing Engineer, Biopeptek Pharmaceuticals

Join Mainline Scientific as a Manufacturing Engineer and take a significant role in the exciting world of bioanalytical technology! Located in the heart of Malvern, Pennsylvania, we focus on creating innovative life science instruments that are both robust and advanced. As a Manufacturing Engineer, you will closely collaborate with R&D engineers to ensure that product designs transition smoothly into production. This is a hands-on position where you will design and optimize manufacturing processes for both new and existing products. You will be instrumental in setting up efficient production lines, developing packaging solutions, and ensuring that our processes meet rigorous regulatory standards. This role is perfect for someone detail-oriented and passionate about driving continuous improvement initiatives that enhance quality, efficiency, and value. We are looking for a professional with at least 2 years of experience in manufacturing engineering, ideally from the instrumentation or high-tech industry. If you have a knack for problem-solving, strong team collaboration skills, and are familiar with tools such as Lean and Six Sigma, we want to hear from you. Come play a pivotal role in shaping the future of our innovative products and join a team committed to excellence and integrity. At Mainline Scientific, we offer a collaborative environment where your contributions make a difference, supported by competitive pay, comprehensive benefits, and opportunities for personal and professional growth.

Frequently Asked Questions (FAQs) for Manufacturing Engineer Role at Biopeptek Pharmaceuticals
What are the main responsibilities of the Manufacturing Engineer at Mainline Scientific?

The Manufacturing Engineer at Mainline Scientific is responsible for designing and optimizing production lines, collaborating with R&D engineers on product designs, implementing packaging solutions, and leading the qualification of manufacturing processes. This role will also involve monitoring production efficiency and driving continuous improvement initiatives.

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What qualifications are required for the Manufacturing Engineer position at Mainline Scientific?

Candidates for the Manufacturing Engineer position at Mainline Scientific should have at least 2 years of relevant experience in manufacturing engineering, preferably in instrumentation or high-tech sectors. A Bachelor’s degree in Engineering or a related STEM field is required, along with strong problem-solving skills and familiarity with ISO9001 QMS.

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Is experience with Lean or Six Sigma important for the Manufacturing Engineer role at Mainline Scientific?

Yes, experience with Lean or Six Sigma methodologies is a plus for the Manufacturing Engineer role at Mainline Scientific. These continuous improvement tools are valuable for driving efficiency and quality in manufacturing processes, aligning with our goal of enhanced product delivery performance.

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What types of products will the Manufacturing Engineer work on at Mainline Scientific?

The Manufacturing Engineer at Mainline Scientific will work on advanced analytical instruments used in the life sciences. This includes everything from prototyping to full-scale production, ensuring that our products meet high standards of quality and compliance.

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What is the work environment like for the Manufacturing Engineer at Mainline Scientific?

The work environment for the Manufacturing Engineer at Mainline Scientific is dynamic and collaborative. It involves hands-on activities in production settings, working closely with cross-functional teams, and engaging in problem-solving initiatives. The position is primarily in-office with a standard workweek of 40 hours.

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Common Interview Questions for Manufacturing Engineer
Can you describe your experience with production line setup in manufacturing engineering?

In answering this question, focus on specific projects where you successfully set up production lines. Highlight your approach to optimizing processes, the tools you used, and the impact your work had on the production efficiency and quality.

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How do you ensure that the manufacturing processes comply with quality standards?

Discuss your knowledge of quality management systems like ISO9001 and your experience in validating manufacturing processes. Mention how you conduct regular audits, implement corrective actions, and collaborate with quality assurance teams.

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What continuous improvement tools have you utilized in your previous roles?

Share specific examples of Lean or Six Sigma tools you've implemented. Explain how you identified areas for improvement and detail the outcomes of your initiatives, such as cost savings or enhanced product quality.

Join Rise to see the full answer
Describe a challenging engineering problem you've solved in a manufacturing setting.

Provide a situation where you faced a significant challenge. Describe the problem, your analysis process, and the solution you implemented. Focus on what you learned and how it improved processes or products.

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How do you communicate effectively with cross-functional teams?

Highlight your interpersonal skills and specific strategies you use for effective communication, such as regular meetings, collaborative tools, and transparency. Give examples of projects where communication was key to success.

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What strategies do you employ for successful collaboration with R&D engineers?

Discuss your approach to collaboration, including early involvement in design discussions and maintaining an open feedback loop with R&D. Illustrate this with examples of joint projects and how you ensured their success.

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Can you explain the importance of product packaging in manufacturing engineering?

Explain how packaging protects the product, ensures compliance, and facilitates logistics. Highlight your experience in developing packaging solutions that meet these criteria and how they impacted overall product delivery.

Join Rise to see the full answer
What role does data analysis play in your decision-making process?

Emphasize the value of data analysis in manufacturing to monitor processes, identify trends, and measure performance. Discuss specific tools or software you use for data analysis and how you've applied insights to improve operations.

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How do you approach process qualification and validation?

Outline your methodology for process qualification, including documentation, testing, and compliance checks. Discuss how you ensure that all processes meet the required regulatory standards before moving into full-scale production.

Join Rise to see the full answer
What qualities do you think are essential for a Manufacturing Engineer at Mainline Scientific?

Discuss qualities such as problem-solving ability, attention to detail, hands-on experience, and good communication skills. Provide reasons why these qualities are particularly important in the context of manufacturing advanced analytical instruments.

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Biopeptek Inc. was founded with vision of improving human life through a dedication to high-quality peptides in research, discovery and clinical innovation, made possible through cutting-edge science and technology. Our specialization in custom pe...

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Full-time, onsite
DATE POSTED
April 24, 2025

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