This position will manage projects, implement process development activities, and provide manufacturing support with compliance to all quality and regulatory requirements. This is a full-time, on-site position in a hands-on R&D 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:

Manage projects related to CNC machining, prototyping, development, and transfer to production.

• Define and manage the project scope
• Create and manage project schedules utilizing Microsoft Project (or equivalent software)
• Manage the project budget with regards to project resources, equipment purchases, and outside contractors
• Determine and manage the resources required for each project
• Lead project meetings with internal and external stakeholders

Other Responsibilities

• Design products, equipment, or fixtures using 3D CAD design and CAM software and transfer to a subtractive manufacturing platform (i.e. CNC mill or lathe), when applicable.
• Operate processing equipment in a specific process area, including but not limited to CNC 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.
• Develop test methods including test method validation using statistical methods.
• 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.
• 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

• Prior hands-on experience with subtractive manufacturing equipment such as CNC mill, CNC lathe, CNC swiss lathe, associated equipment, etc.
• Prior experience with machining polymers and maintaining tight tolerances.
• Prior experience with complex fixturing, work holding, and tool holding for high detail and tight tolerance parts.
• Prior experience with prototype characterization techniques such as mechanical testing, surface profilometry, microscopy, 3D scanning, etc.
• Prior experience with commercial CAM software packages such as MasterCAM, SOLIDWORKS CAM, SolidCAM, or ENCYCAM..
• 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, PathPilot, 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, inspection 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, Project) for project execution and internal communication purposes.
• Good written and verbal communication skills, particularly for team communications.
• Strong conflict resolution skills.
• Fine motor dexterity.

Education/Experience Requirements for the Biomaterials/Design Engineer:

Required- Bachelor’s Degree with 3 years industry experience

Preferred- Bachelor’s Degree or Advanced Degree (M.S. or Ph.D.) with 5+ years industry experience and project management 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: $75,000.00 - $95,000.00 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

Application Question(s):

• Do you have a bachelor's degree in engineering or a related degree?
• Will you now or in the future require employer sponsorship for employment visa status (e.g., H-1B)?

Education:

• Bachelor's (Required)

Experience:

• CNC: 3 years (Required)
• Project management: 3 years (Required)
• FDA regulations: 1 year (Preferred)
• project budget: 1 year (Required)
• Microsoft Project: 3 years (Preferred)

Work Location: In person