Description
\t\t\t\t\t- Conceptualize, design and develop new devices or elements of new devices with the intent of commercialization per Quality System Requirements- Participate as a technical lead on multiple cross-functional development teams that manage projects from concept through commercialization.- Design, assemble, and evaluate prototype devices/assemblies in order to assess technical feasibility of various solutions.- Support accurate and efficient translation of user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, and test method, and procedures while adhering to design controls best practices.- Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.- Communicate deliverable status cross-functionally to facilitate the product development process.- Serve as technical lead for given projects/products, identifying, developing, and implementing solutions to complex problems.- Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance.)- Author protocols and reports including engineering studies using basic statistical methods.- Communicate with outside suppliers for component and equipment sourcing and refinement.- Assist or own verification and validation activities through regulatory clearance and design transfer, including building finished devices for the purposes of verification/validation.- Contribute to design/development of product line extensions and product improvements.- Mentor peers and junior engineers to advance R&D department technical ability and core competencies.
\t\t\t\t\tSkills
\t\t\t\t\tMedical device, New product development, Iso 13485, R&d, Solidworks, R&d engineering, Product design, Mechanical engineering, injection moulding, extrusion process, fixture design, tooling design, new product introduction, test method, project management
\t\t\t\t\tTop Skills Details
\t\t\t\t\tMedical device,New product development,Iso 13485
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t- Bachelor’s Degree in Engineering or related technical field and 5 years related work experience- Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required.- Must possess knowledge, understanding and skills in: generating new product designs/concepts, catheter materials, processes and design plus test methods and metrology; project management, documentation, design control methodology, and a working knowledge of quality systems and medical device regulations.- CAD design using Solidworks.- Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.- Experience taking products through the development process to launch.
\t\t\t\t\tExperience Level
\t\t\t\t\tExpert Level
Pay and Benefits
The pay range for this position is $100000.00 - $125000.00/yr.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!
Workplace Type
This is a fully onsite position in Maple Grove,MN.
Application Deadline
This position is anticipated to close on May 20, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.