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Company

Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.

Regional Sales Director, West Coast – Position Summary

  • Sell 3D printed medical device services, including part design, productization and manufacturing to small and medium size medical device companies and medical entrepreneurs looking to develop innovative new devices.
  • Identify, screen and monetize opportunities, working with the company’s senior management and project teams.
  • The scope of opportunities includes 3D printed plastic and metal devices, but with a primary focus on volume (not patient matched) 3D printed titanium and PEKK implants and stainless steel instruments.

Primary Responsibilities

  • Work with the senior management team to prioritize primary business segments and prospects, using collective knowledge and experience as well as market intelligence
  • Deliver impressive and convincing presentations to prospects, clearly communicating PrinterPrezz’s story and value proposition
  • Develop acquisition strategies based on PrinterPrezz’s capabilities and differentiation, with fluid use of a range of business models and monetization strategies
  • Work with the project team(s) – design, regulatory, quality and manufacturing – to manage opportunities from inception to productization, insuring clear and timely customer communication
  • Manage existing PrinterPrezz accounts and identify new business opportunities to grow revenue
  • Deliver a superior customer experience compared to competitors
  • Meet sales metrics and revenue quotas
  • Provide senior management team with multi-quarter revenue forecasts
  • Provide senior management team with regular field intelligence reports covering target applications and customers, new opportunities and competition

Qualifications

  • 10+ years experience developing, marketing and selling medical implants, preferably spine, knee and hip, with any 3D printed product experience a plus
  • Significant experience with medical implant product development cycles and NPI processes, including prototyping, V&V and manufacturing
  • Proven achiever who consistently meets sales targets
  • High energy, self-motivated and independent
  • Projects passion, enthusiasm and confidence
  • Drawn to participating in emerging, high-growth business opportunities
  • Comfortable working in a dynamic company environment and contributing to an evolving business focus and strategy
  • Possess a basic understanding of USFDA QSR and 510(K) filings
  • Experience with 3D printing and associated implant design considerations and is a plus
  • Capable of becoming a recognized PrinterPrezz brand ambassador

Other

  • Competitive compensation plan with significant commission potential.
  • Work from home office, but with 50%+ travel to prospects, customers and Fremont, CA headquarters.

Job Type: Full-time

Company

Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.

Sr. Validation Engineer Job Description

Looking for a highly motivated and experienced Sr. Validation Engineer to partner with our Product Development and Manufacturing team’s initiatives and maintain QMS compliance with the applicable Standards and Regulations. As a Sr. Validation Engineer, you will be a Subject Matter Expert (SME) and also lead the validation process execution for the organization as well as specific customer project scope with a focus on 3d Additive Manufacturing, GMP Process Equipment, Facilities, and Utilities.

This individual must plan, write, and execute Engineering validation protocols, reports and other technical documents, as well as conduct validation related investigation for our laboratories and manufacturing, processes, rooms and equipment. This position requires knowledge of process validation principals, manufacturing controls, and application for Medical Device standard such as ISO 13485 and QSR 820 requirements.

Essential Duties and Responsibilities

  • Participate and lead project teams executing various validation projects for the accomplishment of validation plans
  • Manage validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports
  • Generate/Revise/Manage Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various life science lab, computer system, manufacturing and packaging equipment and utilities.
  • Execution of Test Protocols, including identification and resolution of non-conformances/deviations.
  • Execute Installation, Operation and Performance Qualification Protocols for various life science lab, computer system, manufacturing and packaging equipment and utilities.
  • Participate in issue identification, investigation, and mitigation. Generate test problem reports.
  • Support processes, rooms and equipment improvement projects that require validation support
  • Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts
  • Generate associated validation summary reports.
  • Provide routine progress and issue update to project team.
  • Perform temperature mapping and other miscellaneous validation activities.
  • Lead Validation teams in executing routine Validation deliverables in a staff augmentation role.
  • Perform and document statistical analysis related to validations
  • Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new processes, rooms, and equipment, and/or improvements
  • Train operations or laboratories staff on protocols, procedures and technical details related to systems, equipment
  • Provide consultation to other departments performing validation activities
  • Manage contractors supporting validation projects
  • Manage validation equipment in compliance with Quality System Requirements
  • Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions
  • Identify areas and opportunities to improve manufacturing facilities, processes, and equipment
  • Other duties as assigned

Required Education and Experience

  • Bachelor’s degree in engineering
  • 10+ years of Manufacturing, Quality Engineering, and/or engineering experience in a Medical Device regulated environment
  • Strong knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis
  • Knowledge and working application of FDA, ISO 13485 and cGMP requirements
  • Experience in leading Validation team and projects
  • Experience in the biotech, medical device industry in the development and deployment of manufacturing processes, process controls, and continuous improvement methods
  • Ability to deliver results under minimum supervision to accomplish goals while working across departments is required
  • Demonstrated strong analytical problem solving, team collaboration, and communications/interpersonal skills
  • Excellent interpersonal, written, and verbal communication skills
  • Adaptable to fast-paced, dynamic work environment with ability methodically manage projects
  • Cleanroom Environments (HVAC), Clean Steam and process gases.
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
  • Able to function efficiently and independently in a fast paced, changing environment.
  • Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics etc.

Physical Requirements

  • Remaining in a stationary position, often standing, or sitting for prolonged period of time
  • Sedentary work that primarily involves sitting/standing for prolonged periods of time
  • Adjusting, moving, or lifting objects up to 30 pounds
  • Repeating motions that may include the wrists, hands and/or fingers
  • You may be requested to operate machinery on occasion

Job Type: Full-time

Company

Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.

Medical Device Project Manager Position Summary

  • Work with company’s sales and manufacturing teams and prospects to manage 3DP medical device development and manufacturing projects from inception through regulatory approval, ensuring a clean handoff to manufacturing.
  • Productize and monetize the company’s medical device development know how to maximize customer acquisition and product development revenue potential.
  • Lead product commercialization efforts for major third party and OEM implantables, including design and prototyping, V&V and manufacturing and regulatory documentation.
  • The scope of opportunities includes 3D printed plastic and metal implantables, primarily Class II, but with a strong focus on volume 3D printed implants and instruments.

Primary Responsibilities

  • Work collaboratively with Marketing, Operations and Sales to understand customer requirements and production timelines.
  • Collaborate with partners, contract manufactures, and specialists to optimize designs for manufacturability and product quality.
  • Lead design control activities for new product development (NPI) from initial concept and prototyping through commercialization.
  • Perform troubleshooting on products/processes as related to design, material, or process.
  • Manage verification and validation activities to ensure product designs meet customer requirements. Establish build qualification metrics and product acceptance criteria.
  • Generate documentation relevant to design control and other applicable regulatory requirements.
  • Develop and manage medical device product launch plans and schedules and lead cross-functional commercialization teams.
  • Communicate effectively with customers and the sales and manufacturing teams, insuring timely and accurate project updates.
  • Resolve conflicts and deliver scheduled milestones.
  • Ensure compliance with documentation guidelines and hold design reviews in accordance with product development procedures.
  • Maintain proper design controls, risk management and design history files.
  • Complete engineering deliverables for all FDA filings.
  • Lead team in developing, validating, and documenting product, test and process requirements.
  • Generate test protocols, reports and supporting documentation for formal design verification.

Qualifications

  • B.S. in Mechanical or Biomedical Engineering or other relevant engineering field.
  • Minimum 5 years of experience in product development for medical devices, preferably orthopedic implants in an ISO 13485 and 21 CFR Part 820 environment.
  • Experience with orthopedic implant design, prototyping and development activities.
  • Proficiency maintaining design control activities for new product development from first article of inspection (FAI) through commercialization.
  • Experience developing and leading verification and validation activities for customer design projects.
  • Knowledge in additive manufacturing (DFAM) and understanding in developing process specifications to control product quality a plus.
  • Hands-on design and prototyping skills and proficiency in SolidWorks and ideally FEA.
  • Ability to create procedures, work instructions, and forms to ensure compliance with regulatory requirements.
  • Demonstrated ability to develop detailed project schedules and manage execution.
  • Strong verbal & written communication skills including ability to present technical information before peers, leadership, surgeons, and outside partners
  • Experience with scripting and programming for design.
  • Ability to create engineering drawings, including assignment of dimensions and tolerances to designs.
  • Ability to solve complex problems, deliver on assigned tasks on time and work with minimum guidance and supervision. Knowledge of conventional manufacturing processes and ASTM Standards (complementary to AM processes, such as CNC machining, inspection, coating, plating, infiltrating, painting, injection molding, casting, investment casting, etc.).

Job Type: Full-time

Company:

Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.

Responsibilities:

  • Provide organization with a broad and detailed understanding of the financial health of the firm and the impact of current actions/results as they relate to future profitability/liquidity.
  • Prepare financial forecasts, including operating budgets, financial and cash flow projections
  • Support pricing decisions, evaluate profitability, and provide quantitative insights on organizational initiatives
  • Responsible for all accounting functions within the Company, and adherence to Generally Accepted Accounting Principles (GAAP).
  • Responsible for evaluating and implementing accounting systems, policies and procedures to ensure maximum efficiency
  • Responsible for preparation of tax docs, as well as all banking relationships, and all insurance renewals, securing adequate coverage, with lowest rates.
  • Responsible for adherence to all cities, State and Federal regulatory requirements, as they relate to accounting functions, within stated time frames as dictated by these various agencies.
  • Provide upper management with accurate and timely analysis of the company’s financial status and progress – these should reflect historical as well as future trends.
  • Interface with project managers on “costs to complete” and monthly WIP adjustment.
  • Provide financial management support on projects as needed.
  • Oversee ongoing finance and accounting processes, including cash management, expense management, customer invoicing, collections, and financial reporting
  • Ensure that the company’s processes are clearly documented with standardized processes and procedures.

Requirements:

  • CPA
  • 4+ years’ experience in Finance
  • Medical device or contract medical manufacturing industry experience
  • Must possess strong skills in budgeting, forecasting, financial analysis and dashboard reporting and projections.
  • Prior experience in AP, AR, and all matters relating to producing accurate financial statements
  • Proficient with Microsoft Office Suite (Excel, Word, PowerPoint).
  • Excellent problem-solving skills.
  • Strong verbal and written communication skills.
  • Highly self-motivated, accountable, and results oriented.
  • M&A evaluation and IPO preparation experience preferred
  • Experience in a startup environment is a plus!

Job Type: Full-time

Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.

Job Description:

The VP Manufacturing is responsible for managing the 3D printing and associated post-processing facility in PrinterPrezz’s Fremont, CA location as well as relationships with the Company’s post-processing partners. PrinterPrezz is a medical device manufacturer that utilizes 3D printing and complies with ISO 13485 and FDA CFR 21 Part 807. The candidate must be able to manage day-to-day operations in detail as well as select and implement tools, processes and metrics that allow the operation to scale efficiently over time. Key metrics include on-time-delivery and scrap rate and key internal relationships include VP Quality and VP Customer Care. The position reports to the Chief Revenue Officer (CRO).

Responsibilities:

  • Maintain compliance with the Quality Management System (QMS), FDA Regulations, OSHA Regulations, and ISO13485 requirements.
  • Provide technical support for Material Review Board (MRB) and CAPA reviews
  • Facilitate resolution of complex manufacturing issues through cross functional teams.
  • Plan and track production to ensure products are delivered on-time and target costs are achieved.
  • Ensure all material received conforms to specifications and Maintain strict material handling practices
  • Own the factory layout and processes. Design the Factory for modularity, adaptability, and efficiency, with an eye for scaling with time and product evolution.
  • Apply lean and six sigma tools as appropriate to optimize and improve operational performance.
  • Review engineering drawings to assess designs for manufacturability.
  • Serve as SME on manufacturing equipment and help characterize and validate production equipment
  • Analyze mechanical failure data and implement or revise the equipment reliability and preventative maintenance plans as required to improve Safety, Overall Equipment Effectiveness (OEE), and life cycle costs.
  • Maintain Inventory levels and control flow of product to achieve efficient production and warehouse operations
  • Drive the development of business tools and implementation of IT Systems (ERP, MRP, MES, BPM, etc.) to enable high-quality, efficient manufacturing.
  • Ensure safety program meets EH&S requirements
  • Ensure manufacturing areas are maintained in a clean, organized, and safe manner utilizing 5S principles
  • Help define and measure progress by standards of performance. Performance measurements may include overall equipment effectiveness (OEE), inventory tracking, targeted yields, rejects/scrap, non-conforming records, etc.
  • Help develop and implement process control measures and evaluate results through statistical analysis
  • Help select and qualify suppliers based on product requirements and monitor their performance.
  • Help implement in-process quality control measures.
  • Actively promote a culture of safety and quality.
  • Maintain connections with industry and professional organizations and stay informed of new technology.

Requirements:

  • Bachelor of Science in Mechanical, Manufacturing, Industrial or Aerospace Engineering (other relevant fields may apply) from an accredited university required; Master of Science preferred.
  • 4+ years of direct manufacturing and manufacturing engineering experience
  • 2+ years’ experience leading manufacturing engineers
  • Broad knowledge base of manufacturing processes and mastery of engineering fundamentals for manufacturing and design for manufacturing
  • Understanding of manufacturing, supply chain management, inventory management, etc especially within small batch and high mix low volume business
  • Successful track record developing/starting new manufacturing processes
  • Experience with manufacturing in a regulated industry; medical device manufacturing is a plus
  • Understanding and demonstrated application of Six Sigma and Lean principles; Green Belt a plus
  • Understands key drivers of manufacturing financial variances including, absorption, spend, material usage variance, scrap, etc.
  • Strong coordination, personnel, and project management skills
  • Experience in a startup environment is a plus

Job Type: Full-time