This position will involve R&D project activities with compliance to all quality and regulatory requirements. This is a full-time, on-site position in a hands-on laboratory and manufacturing environment. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.
Responsibilities for the Role:
- Design products, equipment, or fixtures using 3D CAD design software and transfer to an additive manufacturing platform, when applicable.
- Operate processing equipment in a specific process area, including but not limited to additive manufacturing equipment, testing equipment, and post-processing equipment such as ultrasonic washers and UV curing systems.
- Design experiments to provide data based conclusion about a process or product performance.
- Perform or coordinate characterization testing as needed for part characterization (i.e. mechanical testing) and communicate results to project stakeholders.
- Procure and implement new testing and manufacturing equipment using IQ/OQ/PQ validation techniques.
- Conduct or support process validation activities.
- Assist in project tasks planning, coordination, and execution.
- Perform literature searches for study design inputs.
- Using GDP practices, maintain laboratory notebook and write technical reports detailing procedures, outcomes, and observations.
- Recommend and rationalize specifications for development products.
- Write technical reports detailing procedures, outcomes, and observations.
- Interface cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition medical device prototypes into manufactured components.
Required/Preferable Knowledge, Skills and Abilities for the Role:
- Prior hands-on experience with additive manufacturing equipment such as VPP, SLA, FFF, etc.
- Prior experience with 3D printing materials such as PLA, ABS, TPU, etc., and VPP analogs.
- Prior experience with prototype characterization techniques such as mechanical testing, surface profilometry, microscopy, 3D scanning, etc.
- Prior experience with commercial 3D printing software packages such as Simplify3D and PreForm.
- Prior experience with creating/editing drawings using 3D CAD design software. Preferred experience with SOLIDWORKS.
- Prior experience with drawings for machining purposes with associated tolerances and specifications.
- Prior experience with software or controller programming languages such as G-Code, Duet3D, Python, VBA, PLC, Arduino, C++, etc.
- Prior engineering experience within a manufacturing environment.
- Familiarity with material characterization analytical techniques as inputs for downstream processing such as DSC, GC, IV, Rheology, UV-Vis, HPLC, etc.
- Familiarity with manufacturing automation systems and components such as PLC programming, electronics, conveyor systems, etc.
- Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
- Prior experience with performing test methods in accordance with FDA, ISO, ASTM, or USP standards.
- Ability to handle confidential business information.
- Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab.
- Understanding of cause-effect relations between process inputs and product specifications.
- Understanding of the effect of a process on downstream steps or customer needs.
- Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.
- Good written and verbal communication skills, particularly for team communications.
- Fine motor dexterity.
Education/Experience Requirements for the Biomaterials/Design Engineer:
Required- Bachelor’s Degree with 0 years industry experience
Preferred- Bachelor’s Degree or Advanced Degree (M.S. or Ph.D.) with 3+ years industry experience
Example applicable degrees include: Mechanical Engineering, Chemical Engineering, Bioengineering, Electrical Engineering, and Materials Science
Working Conditions at Poly-Med, Inc.:
At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.
Physical Requirements:
Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.
Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.
Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
Job Type: Full-time
Job Type: Full-time
Pay: $60,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Education:
Experience:
- mechanical testing: 1 year (Required)
- SolidWorks: 1 year (Required)
- hands-on laboratory: 1 year (Required)
- Cell culture: 1 year (Preferred)
- 3D Printing: 1 year (Required)
Work Location: In person
