Job details
Job type full-time
Full job description
Remote work may be possible for well-qualified candidates.
Primary functions
The primary functions include planning and executing tasks associated with medical device product development, including but not limited to: project planning, design, analysis, testing, and documentationIn addition, the senior product development engineer will be expected to directly communicate with partners to effectively accomplish project tasks.
Qualifications:
To perform this job successfully, an individual must be able to perform each of the major responsibilities, including the following:
Technical:
Perform moderate to advanced product development tasks in accordance with sop06 with moderate guidance:
Identify design requirements and generate novel engineering solutions
Conduct market and intellectual property research and analyses
Produce robust engineering models and drawings using solidworks
Perform engineering analyses such as stress, fea, basic failure analysis, tolerance stack, material selection and fmea.
Apply a working knowledge of relevant manufacturing processes to optimize design for manufacturability
Develop and execute test protocols, interpret results, 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
Participate in and/or lead design review and/or design transfer activities
Perform effective time/project management activities
Leadership:
Participate in and/or lead project management tasks such as regular planning events, partner communications and resource coordination.
Provide technical and project related direction and instruction to product development team members.
Draw upon external resources for expertise as necessary
Participate, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives
Communication:
Lead effective communication efforts with internal and external stakeholders regarding status, timing, budgetary and design issues impacting the project.
Build and maintain effective relationships with internal and external stakeholders.
Create and deliver project presentations to internal and external audiences
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or experience:
Bachelor`s degree in mechanical or other related engineering disciplines and 5 years relevant design experience, or master`s degree and 4 years` experience, or phd degree and 3 years` experience.
Prior experience with orthopedic medical device development is preferred.
Demonstrated ability to leverage manufacturing process and material knowledge in engineering designs
Proficient in solid modelingExperience with solidworks is preferred.
Proficient with microsoft office applications, including word, excel, powerpoint and project.
Demonstrated ability to successfully manage projects from planning to completion
Basic knowledge of anatomy, physiology and biomechanics is preferred.
Language skills:
Excellent communication skills.
Ability to effectively communicate with all levels of the organization.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.
Reasoning ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several 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 is occasionally required to stand; walk; use hands to handle or feel; reach with hands and arms; and stoop, kneel, crouch, or crawlThe employee must occasionally lift and/or move up to 50 poundsSpecific vision abilities required by this job include close vision, and color vision.
