Product Development Engineer

To be considered for this position please complete the following application: Product Development Engineer 

SUMMARY:
We are seeking a Product Development Engineer to become an immediate and valuable contributor to the Engineering team. The Product Development Engineer is integral to the design, development, and industrialization of our diagnostic products. 

RESPONSIBILITIES:
– Design and develop diagnostic devices and consumables
– Continually optimize manufacturing procedures to produce less expensive, higher quality diagnostic devices and consumables
– Develop and perform test procedures to verify and validate product quality and efficacy
– Document all testing and development activities and then complete design and process change documentation as required
– Assist in the completion of new and existing product design verifications and validations 
– Complete design drawings and models in Solidworks (or equivalent) and create prototypes to progress the development through its design stages 
– Assist in training personnel to processes associated with design and development of diagnostic and accessories 
– Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes
– Assist in the resolution, documentation, and customer responses of product complaints 
– Coordinate and assist in corrective and preventative action activities and solutions
– Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems
– Communicate with strategic vendors and suppliers 

As a Production Supervisor, you’ll bring a proven track record of hands-on
experience participating in and organizing day-to-day production workflow in a
manufacturing setting – preferably relating to medical devices, GMP manufacturing,
and/or any regulated industry. You’ve worked in a deadline driven environment
producing a technical product with a sharp eye for quality while meeting business
output goals. The Production Supervisor will be in constant cooperation with upper
management, logistics, quality, and engineering teams to schedule production
efforts and assure that assembly technicians are effectively managed, trained, and
equipped to build product.
As a Production Supervisor, you’ll b
ring a proven track record of hands-on
exrience participating in and organizing day-to-day production workflow in a
setting – preferably relating to medical devices, GMP manufacturing,
and/or any regulated industry. You’ve worked in a deadline driven environment
producing a technical product with a sharp eye for quality while meeting business
output goals. The Production Supervisor will be in constant cooperation with upper
management, logistics, quality, and engineering teams to schedule production
efforts and assure that assembly technicians are effectively managed, trained, and
equipped to build product.
– Monday – Thursday, 7:00 AM – 5:30 PM 
– Monday – Thursday, 5:00 PM – 3:30 AM
– Friday – Sunday, 7:00 AM – 7:30 PM

Some occasional shift flexibility is required, regular flexibility is preferred. 
The Quality Assurance Analyst is responsible for maintenance and
organization of incoming raw goods and materials for biology
consumable manufacturing as well as quality control testing and
documentation for product in accordance with Biomeme SOPs and
MPIs as well as general regulatory guidelines. This position will report
directly to the Quality Manager and assist in adherence to Biomeme
quality system requirements.
We are expanding rapidly in response to the global pandemic
and are in search of experienced Production Supervisors for
three shifts; Monday-Thursday 7:00 AM-5:30 PM, Monday-
Thursday 5:00 PM-3:30 AM, and Friday-Sunday 7:00 AM-7:30
PM. Some occasional shift flexibility is required, regular
flexibility preferred.
Thuality Assurance Analyst is responsible for maintenance and
organization of incoming raw goods and materials for biology
consumable manufacturing as well as quality control testing and
documentation for product in accordance with Biomeme SOPs and
MPIs as well as general . will report
directly to t assist in adherence to Biomeme
quality system requirements.

We are exp

anding rapidly in response to the global pandemic

and are in search of experienced Production Supervisors for
three shifts; Monday-Thursday 7:00 AM-5:30 PM, Monday-
Thursday 5:00 PM-3:30 AM, and Friday-Sunday 7:00 AM-7:30
PM. Some occasional shift flexibility is required, regular

flexibility preferred.

 

SKILLS:
– Hands-on experience designing, building, assembling, and troubleshooting prototypes
– Experience in regulated industry; Medical Device or Diagnostic preferred 
– Good written and verbal communication skills
– Project management
– Self-starter 
– Strong organizational skills
– Excellent problem-solving skills 

REQUIREMENTS:
– BS/BA in applicable field of study, preferabbly engineering (Mechanical or BioMedical Engineering) 
– 2 – 10+ years of experience; salary will be commensurate with skills and experience


Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3)

Biomeme is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. 

 

 

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