R&D Manager
3.
6 Allen, TX Allen, TX Full-time Full-time Estimated:
$109K - $138K a year Estimated:
$109K - $138K a year 4 days ago 4 days ago 4 days ago As a part of the team, you will be contributing to each of our core beliefs:
Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun.
You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.
Quest Medical, Inc.
is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets.
Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery.
Our company culture is very diverse and the average tenure for our employee population is 7
years.
If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be
Summary:
This position requires an individual to function as both a technical leader and a supervisor of key engineering personnel in the design and development of innovative medical devices for market success.
Area of focus is Mechanical or Biomedical.
This individual should have significant experience managing projects starting from concept through manufacturing and eventual commercialization.
Key focal areas are Cardiovascular, Ophthalmology and Fluid Delivery.
Directly responsible for leading high visibility projects from strategy, planning and administration of the product through all development phases of design, testing, clinical evaluation and production design transfer.
In addition, leads pre-concept efforts and support early strategic market assessments.
Further, provide subject matter expertise for life cycle management of core product lines related to Mechanical and Disposable medical devices.
Requirements:
Bachelor's degree in Mechanical, Plastics or Biomedical Engineering or Science discipline or equivalent with working knowledge of Electronics and Software.
Advanced degree preferred.
Minimum of 10-15 years previous experience, including mechanical product design engineering and project management experience, within the medical device industry.
An individual must be able to perform essential duties satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be a self-starter with demonstrated leadership experience working in a diverse technical setting.
Detail oriented and ability to organize and analyze large amounts of work and data.
This includes the need for good documentation practices.
Have effective oral and written communication skills.
Requires working knowledge of office software and technical software such as CAD-CAD-CAE, Statistics and MS Project.
Plans effectively and team oriented.
Ability to work with little supervision, lead / manage talented engineers, and develop entry-level engineers.
Proven track record demonstrating the development and commercialization of medical devices.
Good oral and written communication.
Ability to read, analyze, and interpret professional/technical journals, scientific literature, procedures, and governmental regulations.
Ability to write routine reports and business correspondence.
Ability to communicate well with individuals at all levels of the organization.
Previous experience in directing the activities of senior to junior experienced Engineers and Technicians.
Knowledge of Cardiovascular surgical procedures, devices, technologies and OR environment preferred.
Duties:
Planning & Strategy Work with Clinical team and market development to define, shape and develop pre-Concept initiatives.
Technical leadership to balance sustaining engineering with new product development.
Core Technical Skills Systems design and architecture, interface with hardware and software Component design, mechanism design for hardware and disposables High degree of competency in rapid prototyping and new product ideation Mechanical and Electro-mechanical component selection and knowledge such as sensors, motors, actuators, pumps, drive systems Working knowledge and use of LabVIEW, MatLAB, FEA software and other analytical tools High degrees of competency with Disposables design, manufacturing and knowledge of plastics, polymers and elastomers.
Process knowledge such as injection molding, extrusion, forming, sheet metal, assembly and automation Root cause analysis, Statistical analysis, Agency certification process and requirements Design Control process, verification, test equipment and design Project management expertise, product cost management Demonstrated ability to interpret technology and market trends as a foundation for technology and product roadmaps.
Product Development Designs and develops innovative and cost effective products to support both short and long term business plans.
Concepts prototype devices utilizing innovative material and process technologies to achieve concept objectives.
Conducts design reviews and performs failure mode and effects analysis.
Leads multi-functional product development teams by coordinating/delegating technical and administrative responsibilities, identifying critical action items and obtaining closure, and following corporate product development guidelines Communicates project status, through verbal and written reports and schedules, to management.
Reviews new product concepts; and in conjunction with a product development team, develops design requirements and project schedules.
Working with team, develops laboratory tests and protocols to assure conformance of prototype devices to performance specifications, FDA regulatory and biocompatibility requirements.
Interfaces with Manufacturing for the fabrication of devices to support both animal and human clinical evaluation along with design transfer to OPS.
Evaluates device performance through animal and/or human clinical investigation; and, as required, implements appropriate product changes to include revision of performance specifications.
Functional Management Hires, trains and coaches Team Leaders, Engineers, and Technicians to thrive in a results-driven environment.
Implements performance management duties including performance appraisals and salary reviews.
Directs and leads team and cross-functional team on product development initiatives.
Matrix responsibility for core team members and support team members.
Sets the standard for other engineers and provides leadership and direction for the growth and improvement of the department and the company.
Provides guidance, advice, and support to engineers and technicians in areas of:
project leadership, technical consultation, documentation, quality, GMP procedures, engineering disciplines, interfaces with other functions, and company policy Notables /
Benefits:
Summer hours available Mid-size company with great company culture that is well diverse Have a voice in the company Average tenure for employee population is 7 years 401k with employee matching available Paid vacation, health/vision/dental, and other excellent benefits An Equal Opportunity Employer Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Experience level:
10 years Schedule:
Monday to Friday Education:
Bachelor's (Preferred)
Experience:
Software:
5 years (Preferred) Medical device:
8 years (Preferred) mechanical product design engineering:
8 years (Preferred) Project Management:
8 years (Preferred) Electronics:
5 years (Preferred) Ability to Commute:
Allen, TX 75002 (Preferred) Ability to Relocate:
Allen, TX 75002:
Relocate before starting work (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
6 Allen, TX Allen, TX Full-time Full-time Estimated:
$109K - $138K a year Estimated:
$109K - $138K a year 4 days ago 4 days ago 4 days ago As a part of the team, you will be contributing to each of our core beliefs:
Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun.
You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.
Quest Medical, Inc.
is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets.
Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery.
Our company culture is very diverse and the average tenure for our employee population is 7
years.
If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be
Summary:
This position requires an individual to function as both a technical leader and a supervisor of key engineering personnel in the design and development of innovative medical devices for market success.
Area of focus is Mechanical or Biomedical.
This individual should have significant experience managing projects starting from concept through manufacturing and eventual commercialization.
Key focal areas are Cardiovascular, Ophthalmology and Fluid Delivery.
Directly responsible for leading high visibility projects from strategy, planning and administration of the product through all development phases of design, testing, clinical evaluation and production design transfer.
In addition, leads pre-concept efforts and support early strategic market assessments.
Further, provide subject matter expertise for life cycle management of core product lines related to Mechanical and Disposable medical devices.
Requirements:
Bachelor's degree in Mechanical, Plastics or Biomedical Engineering or Science discipline or equivalent with working knowledge of Electronics and Software.
Advanced degree preferred.
Minimum of 10-15 years previous experience, including mechanical product design engineering and project management experience, within the medical device industry.
An individual must be able to perform essential duties satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be a self-starter with demonstrated leadership experience working in a diverse technical setting.
Detail oriented and ability to organize and analyze large amounts of work and data.
This includes the need for good documentation practices.
Have effective oral and written communication skills.
Requires working knowledge of office software and technical software such as CAD-CAD-CAE, Statistics and MS Project.
Plans effectively and team oriented.
Ability to work with little supervision, lead / manage talented engineers, and develop entry-level engineers.
Proven track record demonstrating the development and commercialization of medical devices.
Good oral and written communication.
Ability to read, analyze, and interpret professional/technical journals, scientific literature, procedures, and governmental regulations.
Ability to write routine reports and business correspondence.
Ability to communicate well with individuals at all levels of the organization.
Previous experience in directing the activities of senior to junior experienced Engineers and Technicians.
Knowledge of Cardiovascular surgical procedures, devices, technologies and OR environment preferred.
Duties:
Planning & Strategy Work with Clinical team and market development to define, shape and develop pre-Concept initiatives.
Technical leadership to balance sustaining engineering with new product development.
Core Technical Skills Systems design and architecture, interface with hardware and software Component design, mechanism design for hardware and disposables High degree of competency in rapid prototyping and new product ideation Mechanical and Electro-mechanical component selection and knowledge such as sensors, motors, actuators, pumps, drive systems Working knowledge and use of LabVIEW, MatLAB, FEA software and other analytical tools High degrees of competency with Disposables design, manufacturing and knowledge of plastics, polymers and elastomers.
Process knowledge such as injection molding, extrusion, forming, sheet metal, assembly and automation Root cause analysis, Statistical analysis, Agency certification process and requirements Design Control process, verification, test equipment and design Project management expertise, product cost management Demonstrated ability to interpret technology and market trends as a foundation for technology and product roadmaps.
Product Development Designs and develops innovative and cost effective products to support both short and long term business plans.
Concepts prototype devices utilizing innovative material and process technologies to achieve concept objectives.
Conducts design reviews and performs failure mode and effects analysis.
Leads multi-functional product development teams by coordinating/delegating technical and administrative responsibilities, identifying critical action items and obtaining closure, and following corporate product development guidelines Communicates project status, through verbal and written reports and schedules, to management.
Reviews new product concepts; and in conjunction with a product development team, develops design requirements and project schedules.
Working with team, develops laboratory tests and protocols to assure conformance of prototype devices to performance specifications, FDA regulatory and biocompatibility requirements.
Interfaces with Manufacturing for the fabrication of devices to support both animal and human clinical evaluation along with design transfer to OPS.
Evaluates device performance through animal and/or human clinical investigation; and, as required, implements appropriate product changes to include revision of performance specifications.
Functional Management Hires, trains and coaches Team Leaders, Engineers, and Technicians to thrive in a results-driven environment.
Implements performance management duties including performance appraisals and salary reviews.
Directs and leads team and cross-functional team on product development initiatives.
Matrix responsibility for core team members and support team members.
Sets the standard for other engineers and provides leadership and direction for the growth and improvement of the department and the company.
Provides guidance, advice, and support to engineers and technicians in areas of:
project leadership, technical consultation, documentation, quality, GMP procedures, engineering disciplines, interfaces with other functions, and company policy Notables /
Benefits:
Summer hours available Mid-size company with great company culture that is well diverse Have a voice in the company Average tenure for employee population is 7 years 401k with employee matching available Paid vacation, health/vision/dental, and other excellent benefits An Equal Opportunity Employer Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Experience level:
10 years Schedule:
Monday to Friday Education:
Bachelor's (Preferred)
Experience:
Software:
5 years (Preferred) Medical device:
8 years (Preferred) mechanical product design engineering:
8 years (Preferred) Project Management:
8 years (Preferred) Electronics:
5 years (Preferred) Ability to Commute:
Allen, TX 75002 (Preferred) Ability to Relocate:
Allen, TX 75002:
Relocate before starting work (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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