Job details
Job type full-time
Full job description
Remote work may be available for well-qualified candidates
Primary functions
The primary functions include planning, overseeing, and executing projects associated with medical device product developmentTasks include but are not limited to market analyses, project planning, budgeting, design, design analysis, testing, and documentation.
Qualifications:
To perform this job successfully, an individual must be able to perform each of the major responsibilities, including the following:
Performs advanced product development tasks in accordance with sop-06
Identify design requirements and using expert design skills, generate elegant and novel engineering solutions to complex design problems
Conduct advanced market and intellectual property research and analyses, generate recommendations, and execute solutions.
Produce robust engineering models and drawings using solidworks
Perform expert-level engineering analyses such as stress, fea, basic failure analysis, tolerance stack, material selection, and fmea.
Apply an advanced knowledge of relevant manufacturing processes to optimize design for manufacturability
Develop and execute advanced test protocols, perform advanced analyses, interpret results, provide recommendations, and publish associated reports
Create and maintain design history files in accordance with established lincotek medical product development process
Organize and participate, as appropriate, in cadaver labs, surgeries, industry conferences and other product development related activities
Lead design transfer activities
Perform effective advanced time/project management activities
Oversee multiple projects
Provide technical mentorship to the organization
May manage a small team
Other duties as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or experience:
Prefer a bachelor`s degree a four-year college or university in an engineering discipline and more than ten years relevant engineering experience in a cnc machine shop manufacturing environmentPrior experience with orthopedic medical device development is required.
Leadership:
The expectations to meet the minimum job knowledge, skills, and abilities to demonstrate professional leadership include but not limited to:
Lead project management tasks such as regular planning events, partner communications, and resource coordination on multiple projects or initiatives.
Exhibit the capability for strategic thinking and business risk mitigation
Provide technical and project related direction and instruction to product development team members.
Draw upon external resources for expertise as necessary
Serve as an internal resource of technical expertise for other projects as necessary
Initiate, participate in, and/or lead efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives.
Initiate, participate in, and/or lead efforts associated with organizational technical improvements and initiatives
Language skills:
Excellent communication skills, including well developed written, interpersonal, presentation and negotiation abilities
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Mathematical skills
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
Reasoning ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases
Ability to deal with a variety of abstract and concrete variables
Physical demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hearThe employee may occasionally lift and/or move up to 25 pounds normally found in a professional office settingSpecific vision abilities required by this job include close vision, and color vision.
Work environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsWhile performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and risk of electrical shockThe noise level in the work environment is usually moderate.
