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1+ months

Lead Manufacturing Engineer

Kelly Services
Houston, TX 77007
Manufacturing Engineer (Houston, TX)

Our client in medical devices (endovascular medical devices; guidewire, catheters, etc.) is currently hiring a Lead Manufacturing Engineer to guide with design verification processes. This position is a Direct Hire.


You will lead efforts that take products from the lab the way to medical facilities. You will lead efforts conducting material selection and development, manage pre-clinical testing for FDA / ISO standards, support regulatory personnel in preparing premarketing submissions to the FDA (510ks), and, finally, coordinate efforts with manufacturing for market release.


The ideal person for this role would be someone, who, start to finish owned a whole life cycle/ owned the design and development of medical devices through transformation of internal and external inputs into outputs, developing design requirements and specifications, creating test methods and corresponding test method validations, etc.


Background:

Fabrication and integration of class II and class III medical devices.

Design verification- Creation of designs and coordinating design verification activities.

Perform tolerance analyses to ensure component interactions are met.

Maintain compliance to procedures and regulatory requirements.

Writes/update work instructions, part specifications, verification protocols, and other various technical documents.

Work with an interdisciplinary team of engineers/scientists for guidewire R&D.


Expertise and Skills:

Mechanical, Biomedical Engineering or Materials Engineering degree (other Engineering or technical degree is acceptable with prior medical device development experience).

5-10 years engineering experience in the medical device industry in a manufacturing setting. Class II or Class III devices.


Design verification experience.

Must have a strong attention to detail and experience in assembly of small components.

Ability to excel within a fast paced, dynamic, and constantly changing work environment.

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.

Strong planning, technical, and problem-solving skills.

Ability to prioritize and multi-task with little supervision.

Previous work experience should demonstrate "out of the box" thinking, strong conceptual, design, and analysis skills, self-motivation, flexibility, detail-oriented work style.

Ability to develop and integrate metrics into the projects and operations that clearly

demonstrate the value of engineering to the business.

Knowledge of FDA (21CFR 820), ISO standards (ISO 13485), and other regulations as applicable.


Preferences:

Experience with design verification (taking products all the way through, from development to manufacturing to market.

Experience in the medical device industry in a manufacturing setting.

Proven track record of conceptual, design, and development abilities for successful product launches / Demonstrated ability to bring products from concept to market.

Strong in process validations and experienced in working cross-functionally.

Project management skills.

Strong foundation in statistics to complement process validation strength.

Project management, IP development, FDA regulatory requirements.

Product design, process development, engineering management, team building and leadership, design verification and validation, design for manufacturability.


Highly-preferred would be:

3-5 years' experience in an endovascular medical device setting (guidewire, catheter).

Materials science and engineering, polymer engineering or electrochemical engineering background.

R&D of medical device, steerable catheters and guidewires (cardiac, neurovascular).

R&D of electronic materials, electroactive polymers, coatings, polymer composites.

Knowledge of Design, synthesis and characterization of electrodes, coatings and polymer composites.

Previous work or exposure with advanced functional materials, carbon nanomaterials, medical grade materials or fluoropolymers, or other polymer-processed materials (polymer formulations, tape casting, polymer bonding, molding, extrusion).

Exposure to coating materials and processes, such as physical or chemical vapor deposition, electroplating, electroless plating, dispersion coating, electrodeposition.


About our client:

Medical device company that designs and develops the next generation of tip-deflecting or steerable endovascular guidewires, committed to serving unmet clinical needs for patients with life-threatening conditions such as cerebral vascular disorders.


\#TJP2022_SPEC


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-01-14 Expires: 2022-05-21

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Lead Manufacturing Engineer

Kelly Services
Houston, TX 77007

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