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Production Process Engineer

Company Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

 

Job Description

Responsibilities:

  • Support planning and execution for a relocation process from Plant A in Shanghai to Plant B in PA. Assess the needs, create detailed planning, ensure facility preparation, equipment disassembly and transport, and reassembly/optimization at new facility.
  • Initiates Design for Lean Manufacturing in PDLM processes.
  • Accountable for Process Requirements based on Product Specifications from I&D and Manufacturing Requirements.
  • Accountable for process and equipment capability that meets Requirements.
  • Apply lean manufacturing principles. Orchestrates design for lean manufacturing with according inputs to PDLM workflows.
  • Responsible for MF BOM, routing Master data towards release.
  • Establish Inspection and Test Criteria for Philips owned components and assemblies
  • Implement design changes in Philips factories and at suppliers driven by PDLM governed projects.
  • Responsible for resources, planning, quality and cost.
  • Executes the processes and standards in adherence to compliance with safety, regulatory and environmental requirements as well as local laws, company General Business principles and other policies.

Requirements:

  • Bachelor’s degree or above in Mechanical, Industrial, Manufacturing Engineering, or related field. 
  • 5+ years of experience in manufacturing, product development, or industrial engineering in relevant domains, like consumer electronics product or medical device. 
  • Proficiency in CAD software (SolidWorks, AutoCAD) and manufacturing simulations. 
  • Strong knowledge of Lean Manufacturing, Six Sigma, FMEA, and statistical process control (SPC). 
  • Excellent problem-solving, communication, and project management skills. 
  • Good knowledge on QMS (quality management system), like ISO9001, ISO13485, etc.
  • Familiarity with automation manufacture, robotics, and ERP/MES systems is plus.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Average salary estimate

$85000 / YEARLY (est.)
min
max
$75000K
$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 Production Process Engineer, Katalyst Healthcares & Life Sciences

If you're excited about the prospect of joining Katalyst Healthcares & Life Sciences as a Production Process Engineer in Reedsville, PA, you're in for a thrilling opportunity! In this role, you will play a pivotal part in planning and executing a major relocation process from our Plant A in Shanghai to Plant B right here in Pennsylvania. Your attention to detail will be essential as you'll assess needs, create comprehensive plans, and ensure that every piece of equipment is expertly disassembled, transported, and reassembled optimally at the new facility. Applying lean manufacturing principles will be at the heart of your responsibilities, as you orchestrate design processes that promote efficiency and quality. Your expertise in product specifications will guide you as you create Master data releases and establish inspection and test criteria for our components and assemblies. With your strong background in mechanical or industrial engineering and over five years of experience in manufacturing or product development, you’ll be well-equipped to manage resources and maintain compliance while upholding Katalyst’s high standards for safety and quality. Experience with CAD software, lean methodologies, and regulatory knowledge will not only make you shine, but also help ensure our processes remain among the best in the industry. If you’re passionate about driving innovation in clinical trials and medical device manufacturing, this could be the perfect fit for you!

Frequently Asked Questions (FAQs) for Production Process Engineer Role at Katalyst Healthcares & Life Sciences
What are the primary responsibilities of a Production Process Engineer at Katalyst Healthcares & Life Sciences?

As a Production Process Engineer at Katalyst Healthcares & Life Sciences, your primary responsibilities will include planning and executing the relocation process from Plant A in Shanghai to Plant B in Pennsylvania. You'll assess needs, create detailed planning documents, and oversee the disassembly, transportation, and reassembly of equipment. Furthermore, you will initiate Design for Lean Manufacturing and be accountable for ensuring compliance with process requirements based on product specifications and manufacturing needs.

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What qualifications are required for the Production Process Engineer position at Katalyst Healthcares & Life Sciences?

To qualify for the Production Process Engineer role at Katalyst Healthcares & Life Sciences, candidates need to possess a Bachelor’s degree or higher in Mechanical, Industrial, or Manufacturing Engineering, or a related field. Additionally, a minimum of five years of experience in manufacturing, product development, or industrial engineering is essential. Experience with CAD software, lean manufacturing principles, and knowledge of QMS standards like ISO9001 and ISO13485 will greatly benefit candidates.

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How does Katalyst Healthcares & Life Sciences implement lean manufacturing in its processes?

Katalyst Healthcares & Life Sciences implements lean manufacturing principles by promoting efficiency and eliminating waste throughout its production processes. As a Production Process Engineer, you will be responsible for initiating Design for Lean Manufacturing and applying these principles in the planning and execution of projects, ensuring that resources are utilized effectively, and that the workflows in product development and manufacturing are optimized.

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What tools and software are commonly used by Production Process Engineers at Katalyst Healthcares & Life Sciences?

Production Process Engineers at Katalyst Healthcares & Life Sciences frequently utilize CAD software tools like SolidWorks and AutoCAD for designing layouts and components. They may also use manufacturing simulations to optimize processes, along with statistical analysis tools for quality control measures. Familiarity with ERP/MES systems is considered beneficial for streamlining operations.

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What role does compliance with safety and regulatory requirements play for a Production Process Engineer at Katalyst Healthcares & Life Sciences?

Compliance with safety and regulatory requirements is paramount for a Production Process Engineer at Katalyst Healthcares & Life Sciences. Engineers are responsible for executing processes that adhere to local laws and regulations, as well as company safety standards. This includes maintaining quality management systems and ensuring all manufacturing processes are aligned with industry standards, particularly in sensitive areas such as clinical trials and medical devices.

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Common Interview Questions for Production Process Engineer
Can you describe your experience with lean manufacturing?

When answering this question, detail your experience with lean manufacturing methodologies, mentioning specific projects where you applied these principles to improve efficiency. Discuss the tools and techniques you used and any measurable outcomes, such as reduced waste or improved cycle times.

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What CAD software are you proficient in, and can you provide an example of how you've used it?

Share your proficiency with specific CAD software, such as SolidWorks or AutoCAD. Offer an example where your design directly impacted a project, mentioning the challenges you faced and how your design contributed to the project's success.

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How do you manage project timelines and ensure compliance with industry standards?

Discuss your approach to project management, highlighting any specific tools you use for scheduling and tracking progress. Explain how you ensure compliance with industry standards by adhering to quality management systems and maintaining clear documentation throughout the project.

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What challenges have you faced while implementing design changes, and how did you overcome them?

Explain a specific challenge you encountered while implementing design changes. Focus on your problem-solving skills, the approaches you took to address the issue, and the outcome of your efforts.

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How do you prioritize tasks when managing multiple projects?

Discuss your strategies for prioritizing tasks, such as using project management methodologies or tools to evaluate urgency and importance. Share a situation where your prioritization led to successful project outcomes.

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What experience do you have with quality management systems?

Describe your experience with quality management systems like ISO9001 or ISO13485. Provide specific instances where you've implemented these systems in your work, ensuring compliance and improving product quality.

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Can you provide an example of how you’ve applied Six Sigma in your previous roles?

Detail a specific instance where you utilized Six Sigma methodologies to drive process improvement. Highlight the tools used, the problem addressed, and the positive results of your initiatives.

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How do you handle conflicts in a team setting while working on engineering projects?

Discuss your approach to conflict resolution, emphasizing communication, active listening, and the importance of collaborative problem-solving methods. Provide an example where your skills were tested and the conflict was resolved successfully.

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What strategies do you use for effective communication with cross-functional teams?

Elaborate on effective communication strategies such as regular updates, collaborative meetings, and using clear documentation. Mention how these approaches foster better understanding and teamwork on projects that involve multiple departments.

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Why are you interested in joining Katalyst Healthcares & Life Sciences as a Production Process Engineer?

Share your motivation for applying to Katalyst Healthcares & Life Sciences, connecting your passion for healthcare innovation, and how your skills align with the company's mission and values. Highlight aspects of the company culture or projects that excite you.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
March 20, 2025

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