Filtration Group Corp

Research and Design Engineer

Posted Date 2 months ago(10/6/2021 3:02 PM)
ID
2021-4433
Job Locations
US-GA-Fairburn
Company
POREX CORPORATION
Position Type
Regular
# of Openings
1

Overview

Filtration Group is on a mission to make the world safer, healthier and more productive. With a passionate workforce, global footprint and world class engineering and manufacturing capabilities, we are driving innovation and developing solutions across a broad spectrum of applications in the fast-growing and rapidly-evolving global filtration industry. We are committed to maintaining an entrepreneurial culture built on a foundation of trust and in which our leaders exhibit a strong bias for action.

The Company began in 2009 and has rapidly grown organically and through a thoughtful acquisition strategy to be a global leader in the highly attractive filtration industry. Filtration Group has the broadest portfolio of solutions in the industry and has had a particular focus on building a leading platform of solutions focused on the Life Sciences and Indoor Air Quality end markets which are rapidly growing in the current market environment. Filtration Group operates across a wide variety of attractive end markets and produces mission critical products with high replacement rates. Over 80 percent of the Company’s revenue comes from replacement / consumable products, many of which are specified into customer’s products or processes.

With revenues of $1.4 billion, Filtration Group is consistently recognized as the fastest growing and one of the largest filtration businesses in the world and has a global footprint of 141 facilities in 28 countries. Filtration Group has over 6,000 employees who are united in their Mission to make the world safer, healthier and more productive.

Filtration Group is an affiliate of Madison Industries, one of the largest and most successful privately held companies in the world. Madison builds entrepreneurially driven, branded market leaders that are committed to making the world safer, healthier and more productive by creating innovative solutions that deliver outstanding customer value. The team at Madison is committed to building something truly remarkable that long outlasts them while coaching others to reach their highest potential. Madison’s footprint spans across Europe, Asia and the Americas operating over 216 facilities in 45 countries, with over 12,000 engaged employees. Having successfully built market leaders in filtration, medical, safety, instruments, heat transfer, and indoor air quality, Madison generates revenue of $5 billion, with an enterprise value worth well over $7 billion.

Responsibilities

Summary

Porex is an established global leader in one-of-a-kind solutions for the healthcare, consumer, and industrial markets. Our mission is to make the world Safer, Healthier, and More Productive. We have a unique ‘non-corporate’ culture that values a Bias for Action, Trust and an Entrepreneurial mindset. We value our team members and place a strong focus on their development through a robust talent management program. At Porex we run towards problems and opportunities to drive business results. If this sounds like a company that shares your values, then we may have an opportunity for you.

 

We are seeking a Research and Design Engineer to join one of our fastest growing business segments, Porex Life Sciences Institute (PLSI), a Medical Device Manufacturer who is focused on developing medical devices for various applications.

This role will rely heavily on world-class analytical capabilities and business acumen coupled with an ability to quickly develop and help implement identified improvement opportunities. We expect this role to have a continuous improvement mindset and to help drive this culture throughout the organization.

 

Key Attributes

The ideal candidate will be a creative problem solver with an intellectual curiosity coupled with a strong desire for on-going learning and development. They will have a bachelors in engineering (Mechanical, Biomedical or Chemical Engineering), with 4-5 years’ experience in:

  • The medical device design and development or automotive industry
  • Design and scale-up experience in plastics components
  • 510(k) filings
  • QSR and ISO regulatory environments
  • Statistical Data Analysis

They will also be capable of quickly establishing credibility, influencing decision makers, and persuading professionals at all levels. A key attribute will be an organizational development expert who transforms strategy into operational goals and objectives, achieves desired outcomes, and effectively leads people through change.  Candidates should be able to highlight their IMPACT as a leader throughout their organization(s) and able to thrive in a fast-paced and result- oriented environment. 

 

The RDE will:

  • Assist in the development and launch of our new products in the Life Sciences market.
  • Leverage your technical expertise related to medical devices to assist with creating new device designs, maintain technical files, conduct verification and validation studies, conduct risk analysis, and assist with design transfer to manufacturing.

 

Key Deliverables

  • Design Verification Test Plan and Report, including statistical sample size justification.
  • Develop and manage BOM’s, part numbering systems, drawing and model change documentation.
  • Document control using PLM system.
  • Maintain compliance with QMS system compatible with 21CFR-820 and ISO-13485.
  • Create work instructions and standard operating procedures (SOPs) as required.
  • Assist in compliance with documentation, traceability, training and calibration requirements.
  • Assist with the preparation of regulatory submissions.
  • Participate in non-conforming product investigations and CAPAs as needed.
  • Develop and maintain Device Master Records (DMRs), Test Protocols, and Reports.
  • Assist in identifying and qualifying new suppliers.
  • Travel to manufacturing locations to facilitate resolution of manufacturing problems.

 

Core Competencies

  • Ability to find and partner with external vendors to extend testing capabilities for design and development verification activities.
  • Expertise in Statistical Analysis of data.
  • Proactive, with a demonstrated ability to lead, and relishes working with limited direction and oversight.
  • Must have strong interpersonal skills including interacting with hourly manufacturing associates, customers, and suppliers.
  • Excellent relationship building skills and the ability to work effectively in a team environment working across function and business units.
  • Confident and self-aware with excellent interpersonal and communication skills, both written and verbal.
  • Strong analytical abilities and critical thinking skills; strengths in problem solving and root cause analysis.
  • Proficient in Microsoft Office products, including Word, Excel, PowerPoint and Outlook

Qualifications

Education and Experience

  • Bachelor’s Degree in Engineering (Mechanical, Biomedical or Chemical Engineering), equivalent training and/or experience, and direct experience with medical device industry and related QSR and ISO regulatory environments.
  • 4-5 years’ experience in manufacturing required.
  • 510(k) experience high desirable and preferred.
  • Experience in GD&T in design and development specifications.
  • Experience in venting and pressurizing system design and analysis.
  • Background in Injection Molding, Automated Assembly, 3-D manufacturing and PPAP experience as they relate to medical device a plus.
  • DFMEA and ISO 14971 Risk Management experience.
  • Advanced Solidworks Modeling - surface modeling, working with many configurations.
  • Experience with extrusions, rubber compression molding, plastic injection molding.
  • Familiarity with quality processes: IQC, OQC, CAPAs, RCA, 8D and or A3 methodology.
  • Minitab and or experience with process capability analysis.
  • GR&R experience.
  • Fixture design and manufacturing.
  • Ability to review marketing claims and develop test methods and design of experiments to validate performance.
  • DFM and DFA experience.

 

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