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Quick Question:

Do you have a VERIFIABLE Bachelors or higher degree?
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Quick Question:

Within the last 5 years, what role did the following play in your job:
Experience with ISO 13485
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Quick Question:

Within the last 5 years, what role did the following play in your job:
ensuring manufacturing processes are optimized, and technology transfer to manufacturing is seamless.
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Quick Question:

Within the last 5 years, what role did the following play in your job:
driving Continuous Improvement Projects to increase efficiency, improve quality, and reduce costs.
Please note that this position is no longer available.
If you would like to be considered for similar opportunities now or in the future, feel free to apply and/or set up a notifier for yourself.
Manufacturing Engineer - Medical Device
CA - Irvine


Opportunity Snapshot
Top reasons to consider aligning your career with Aspen Medical Products.
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Spotlight Your Talent While Supporting Our Mission to Enhance the Quality of Life for Patients

If you combine strong continuous improvement skills with the ability to drive efficiencies throughout the manufacturing process, this position offers you a number of interesting opportunities. You will:
  • Expand your skills and experience, focusing heavily on product transfers and optimizing efficiencies.
  • Enjoy wide visibility as you work with stakeholders in Irvine and across the globe.
  • Influence improvements, processes and best practices.
  • Take ownership of a variety of product transfers working primarily on our existing product lines with some new product development. 
  • Support strong global expansion at a manufacturer of award-winning medical devices that is debt-free and privately owned.
  • Put down roots at a company with a family-oriented culture and leaders who care about their team members. 
  • Showcase your potential to pursue other opportunities and grow your skills within our organization.
We're looking for a professional with strong experience and an open and flexible mind. This person will have the bandwidth to grow along with us and the disposition to thrive in a dynamic, evolving environment.

At Aspen Medical Products we pride ourselves on making the best products in the industry, products that change people's lives. We have won many industry awards for our medical devices, which are sold through hospitals, medical practices, chiropractors, and pain management clinics. We believe that enjoying your work and making valuable contributions to business are equally vital. To that end, Aspen has been designated one of the Best Places to Work in Orange County by the Orange County Register and the Orange County Business Journal eight years in a row.
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Optimize Manufacturing Processes & Make Improvements at an Award-Winning, Fast-Growing Company

The Requirements
Find out what it will take to qualify for and thrive in this role.
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To be a strong fit for this opportunity you will have:
  • A bachelor’s degree in mechanical engineering or another relevant engineering discipline. Quick question for you - click here
  • 5 or more years of experience in a Medical Device manufacturing environment.  
  • Outstanding project management skills and a history of success with line optimization, preferably in the orthopedics and/or textile / cut and sew industries. 
  • Solid AutoCAD drawing (primarily) and modeling skills, SOLIDWORKS (preferred) or similar. 
  • Experience facilitating and supporting the ECO process.
  • Experience with automation and various types of line equipment and machinery.
In addition, you should have most of the following:
  • Excellent ability to do resource utilization, process planning, process development, write procedures and write test documentation. 
  • Broad engineering experience in manufacturing operations, including new product development, cost reduction, process qualification, fixtures/workstation design and quality engineering. 
  • Knowledge of GMP and ISO 13485 quality system requirements and FDA validation guidelines. Quick question for you - click here
  • Lean Manufacturing, Work Flow Analysis, 6 Sigma, DFM, DFSS and other quality tools.
  • Experienced in the use of Risk Management tools such as FMEA, FTA, etc. 
  • Experience developing workflow analysis, resource utilization & problem-solving methods; CAPA and root cause analysis.
  • Experienced in identifying, proposing, and supporting in quality system improvement initiatives and projects.
  • MS Office computer skills required - Word, Excel, PowerPoint, Visio. 
  • Bilingual English/Spanish a plus.
  • Ability to work independently, and as a strong team member.
  • Ability to multitask and balance multiple projects simultaneously and shift priorities as business needs demand.
  • Self-motivation, high-energy and a committed work ethic. 
  • Ability to travel, when it's safe to do so, domestically and internationally up to 30%.
Pictured: The Vista® MultiPost Therapy Collar is designed to reduce the symptoms of forward head carriage, promoting improved posture and a more natural alignment.
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The Role
If you meet the minimum qualifications, feel free to apply at any time. If you'd like some additional details about the role, please read below.
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Reporting to the Senior Manager of Technical Ops & Strategic Supply, as the Manufacturing Engineer you will take ownership of a variety of sustaining and product transfer projects. You will work with global teams and interface between R&D, Quality and Operations and other stakeholders during existing and new programs to ensure manufacturing processes are optimized, and technology transfer to manufacturing is seamless. Quick question for you - click here

More specifically, your primary responsibilities will include:
  • Establishing and documenting product validation and test protocols and ensuring completion prior to approval and use.   
  • Driving sustaining engineering activities for current products, ensuring manufacturing efficiency and quality targets are achieved.
  • Overseeing tooling design or tooling build, process planning & line layout.
  • Driving Continuous Improvement Projects (CIP) to increase efficiency, improve quality, and reduce costs in process, products and/or materials.  Quick question for you - click here
  • Identifying, testing & validating new or alternate material & processes associated with the change supporting Aspen’s quality management system in establishing sound documentation practices.
  • Ensuring that ECO’s for new and existing products are properly steered through Aspen’s ECO process.
Additionally, you will:
  • Manage the ECO process to ensure all parties at Aspen have all the information needed prior to product release and/or changes and then subsequent BOM release and/or changes.
  • Support the design and procurement of fixtures for manufacturing or value-added services; where applicable utilize CAD drawing tools or 3D modeling to document tooling, fixtures, components, process and products.
  • Interface with R&D on the selection of materials (plastic, foam, and textile) its properties, its strength and its relationship with other materials and synthesis opportunities. 
  • Work with Sourcing/Purchasing, Quality, R&D to identify, validate, and qualify new suppliers or materials; supporting quality/cost improvements in manufacturing and the supply chain. Establish drawing requirements with correct material specs for Ops and R&D.
  • Monitor manufacturing specifications, identify product and process metrics and report on product quality performance trends.
  • Oversee the qualification of new products into manufacturing through product release; support the implementation of new quality procedures and process controls. 
  • Work with Sourcing/Purchasing, Quality, R&D to identify, validate, and qualify new suppliers or materials; supporting quality/cost improvements in manufacturing and the supply chain. Establish drawing requirements with correct material specs for Ops and R&D.
  • Implement testing program both for R&D and production parts – pre and post qualification; develop validation plans and protocols for parts, processes, and equipment.
  • Implement process control procedures in Irvine and at supplier locations for manufacturing; assembly line design optimization and Kaizen activities.
  • Manage supplier validations/production line reviews/process improvements. 
  • Sustaining engineering of all products and manufacturing processes; Component consolidation/reverse engineer products 
  • Drive Continuous Improvement Project (CIP) management and tracking for process efficiency, cost reductions, quality improvements.
Note: This description is intended to give you a general overview of the position and is not an exhaustive listing of duties and responsibilities.
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Why Join Us
More great reasons to join our team.
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Autonomy and support
We’ll look to you to achieve goals independently and assume ownership of your areas of responsibility. At the same time, you’ll have support when you need it and plenty of opportunities to collaborate with Engineering teams in Irvine, Scotland and Tijuana. Our goal is to set you up for success, and support you throughout your role.

Build a progressive career
We are proactive about supporting professional development. We offer training that helps employees develop both technical and leadership skills, and we're committed to promoting from within whenever possible.

Award-winning products enhance the quality of people's lives
Backed by over 25 years of R&D, Aspen Medical Products help patients cope with chronic conditions, manage pain, and heal faster (see testimonials in the video on The Role tab). Our innovative approach and strong business model have earned us distinctions. In addition to the workplace excellence awards mentioned above, we have won:
  • Several Spine Technology Awards from Orthopedics This Week.
  • The American Technology Award, in the medical device category, from TechAmerica Foundation.
  • Awards for delivering exceptional service as a vendor, from Hanger/SPS, a leading distributor of orthotic and prosthetic patient care and therapeutic products, services and solutions.
  • And others.
Exemplary culture
You will find a close-knit culture that values mutual respect at Aspen. The numerous "Best Places to Work" awards we've won represent high levels of employee satisfaction (as reported by employees) as well as excellence in benefits, pay, work/life balance and culture.

Competitive benefits package
The health, satisfaction and security of you and your family are important to your well-being and important to us. We offer a competitive salary and bonus opportunity; medical, dental and vision benefits for you and your family; life insurance; paid vacation; and a 401(k) plan with company match. 

Pictured: Just a couple of the many awards we have received.
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Road to Success
Find out what it takes to stand out in this role.
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To be successful in the Manufacturing Engineer role, you will be a talented engineer who can leverage your past experience and skills to make an impact on our current manufacturing environment. We will look to you to identify areas for improvement and make an impact right off the bat. You'll also have a deep understanding of Good Engineering Practices (GEP) and the ability to move the needle to drive projects forward.   

Additionally, to find success in this role you will be:
  • A high energy, go-getter
  • Self-motivated with a "roll up your sleeves and get it done" attitude
  • Adept at working independently while also knowing when to seek assistance
  • An outstanding communicator
  • Always on the lookout for improvements
  • Committed to learning and improving your skills, filling in any gaps
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Aspen Medical Products is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.