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Salary3D Systems Healthcare is seeking a Product Development Engineer to develop new medical device technologies from product concept to commercialization. The successful candidate should have experience with digital surgical planning workflows, 3D printing technologies, and medical device design controls. This role requires excellent communication across a variety of stakeholders including strategic partners and key opinion leaders. This role will champion projects with cross-functional team members to deliver products and meet market needs and organizational objectives.
Primary Job Functions:
- Lead and support projects for product enhancements and new product initiatives
- Interface with key opinion leaders, customers, leadership, and cross functional teammates to define and develop product requirements and market analysis
- File invention disclosures and work with IP counsel to conduct freedom to operate analysis
- Own the design history file for new products
- Create prototypes, concept drawings, and feasibility parts for testing
- Construct verification and validation test plans, test protocols, and reports
- Author the device master record documentation such as material specifications, standard operating procedures, work instructions, etc.
- Ensure Product Development activities are in accordance with the 3D Systems QMS in addition to medical device regulations
- Support 510(k) submissions
- Assist with marketing and promotional activities for the Healthcare team
- Represent 3D Systems Healthcare at conferences, customer meetings, and clinical investigation activities
Qualifications
Education:
- Bachelor's degree in Mechanical, Biomedical, or related engineering discipline required.
Experience:
- Background in medical device environment with experience in new product or process development
- Demonstrated ability in 3D printing and digital workflows for creating patient matched medical devices
- Demonstrated ability in understanding user needs and design requirements
- Knowledge of concepts and practices of V&V requirements, Risk Management, FDA and ISO regulations.
- Understanding and experience with medical device design controls and regulatory requirements preferred
- History of strong problem solving, decision making, root cause analysis, and interpersonal skills
- Project management experience is highly preferred
Compensation and Benefits
- Salary Range: $68,300 - $81,900 annually (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data)
- In addition to a salary, this position is eligible for an annual bonus based upon company performance.
- 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 8 holidays per year are also provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.
Applications accepted online through March 26, 2024
3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin or because he or she is an individual with a disability or a disable veteran, Armed Forces service medal veteran (referred to collectively as "protected veterans"). The Company also provides applicants with equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including, but not limited to, lactation.
Primary Location: US-CO-Littleton
Work Locations: USA-CO-Littleton
Job Level: Entry Level
Travel: Yes, 10 % of the Time
Type of Position: Employee
Job Posting: Mar 5, 2024, 3:00:05 PM
