Pioneer Surgical Technology, located in historic Marquette, Michigan is a dynamic medical device corporation that designs, manufactures and markets a broad range of spinal and orthopedic devices. From highly skilled machinists to forward-thinking biomedical and project engineers, Pioneer seeks exceptional individuals who embrace our goal to foster a creative and inventive spirit that advances the cause of medicine, especially in the field of biomedical engineering. Pioneer offers excellent working conditions, competitive salaries and a full range of benefits to its growing workforce. The Pioneer team is dedicated to the company's mission of working to improve the quality of medical care worldwide through the development of new and innovative medical devices. If you think you have what we are looking for and enjoy the quality of life that Michigan's Upper Peninsula has to offer, we welcome your résumé.
Post-Marketing Clinical Studies Coordinator, Biologics (NC)
Biologics Sales Specialist - Western Region US (Southern CA)
Senior Accountant
Quality Systems Associate
CNC Operator
Quality Technician (2nd shift)
Project Manager
Project Engineer
Engineer II - Product Development (Austin, TX)
Senior Engineer - Product Development (Austin, TX)
Program Manager - Product Development (Austin, TX)
- scheduling investigator meetings/site visits
- maintaining study documentation
- coordinating and assisting in site training as needed
- assist in site monitoring as needed
- assist in protocol preparation
- coordinate IRB submissions
- monitor and coordinate data collection
- coordinate studies with Pioneer’s Regulatory and Clinical study groups
- prepare submissions to the Pioneer clinical study committee
- coordinate study submissions for clinical meetings and publications
- undergraduate degree in a health science with a minimum of 2 years clinical trial experience
- extremely organized and able to handle multiple projects in diverse geographic locations
- familiar with all aspects of clinical study documentation
- experience in clinical study monitoring
- experience in clinical study site training
- experience with IRB submissions
- experience creating CRF’s and other study documents
- be knowledgeable about GCP
- experience working with surgeons and OR procedures
Position is located in Greenville or Raleigh, NC.
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Responsible for coordinating and managing biologic sales strategies and tactics to achieve biologic product sales goals
- Achieve sales and profitability goals utilizing ethical business and sales practices.
- Coordinate and implement regional (and national if required) sales activities to gain distributor, hospital, and surgeon acceptance of Pioneer Surgical Biologic products. Sales activities include but are not limited to: Develop and communicate effective product information both orally and otherwise to decision makers, assist sales agencies with in-service to hospitals, OR staff, participate in surgical cases and provide technical support to distributors, hospital, and surgeons as needed.
- Develop and train regional (and national if required) sales agents on correct usage of Pioneer Biologic products.
- Participate in marketing development team to effectively communicate product message, Execute marketing tasks as directed by biologics management.
- Bachelor’s degree in science related field
- Related corporate medical device experience, preferably in biologics and/or tissue engineering
- Team leadership, effective interpersonal and effective delegation skills
- Proficient in computer software applications, excellent computer knowledge
- Establish and maintain effective working relationships with those contacted in the course of business and those with supervisory responsibilities
- Strong interpersonal and written/verbal communication skills
- Ability to function well in a team environment and function independently a must
- Establish and maintain effective working relationships with those contacted in the course of business
- Ability to manage several complex projects in parallel a plus
- Frequent overnight travel within the US/international required.
Position is located in Southern California
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Assist AR/AP staff in day to day activities
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General cost accounting knowledge to assist cost accountant
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Journal Entry Preparation
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General Ledger Maintenance
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Account Reconciliations & Roll forwards
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Fixed Asset Accounting
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Consolidated Financial Statement Preparation
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Review P&L for proper expense classification
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Balance Sheet Analysis
- CPA, preferably audit experience with public accounting experience
- 3 years of experience with general GAAP and Internal Control knowledge
- Experience working with SAP is a plus
- Bachelor's degree in Accounting
- Microsoft office skills
- Some tax experience/knowledge would be helpful
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- Document auditing, organization and maintenance
- Root cause and corrective action analysis
- Team oriented participation in document and quality records projects
- Attainment of positive business results through improvement projects
- Collaborate with process owners to improve operational effectiveness
- Support Pioneer in being an industry leader in quality and innovation, maintaining a productive, friendly, and enjoyable work environment, being a valuable Corporate Citizen which contributes to the greater good and providing value to its shareholders -- which include all Pioneer employees
- Auditor to review Pioneer’s systems for continued improvement.
- Change agent and medical device experience is highly valued.
- Communicate clearly and concisely, both orally and in writing.
- Establish and maintain effective working relationships with those contacted in the course of business, and those with supervisory responsibilities.
- Maintain effective discretion and perception needed for making observations, communicating with others, reading and writing and operating assigned equipment
- Maintain mental capacity which allows the capability of making sound decisions and demonstrating intellectual capabilities
- Ability to manage several complex projects in parallel a plus.
- Results oriented visionary.
- Strong computer skills including Microsoft Office
- Experience in Medical Industry a plus
- Education beyond High School a plus
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- Operate computer numerically controlled equipment
- Perform in-process quality checks
- Perform light equipment maintenance
- Monitor tool condition, stock levels and fluid levels
- Previous CNC experience or completion/enrollment in CNC certification program desired
- High school education or equivalent
- Basic computer and math skills
- Geometric Dimensioning & Talerancing, Print reading
- Work in fast paced, high volume area
- Detail oriented
- Follow procedures
- Team player
- Safety oriented
- Great hands-on skills
- Reliable, motivated individual
- Communicate clearly and concisely
- Establish and maintain effective working relationships with those contacted in the course of business and those with supervisory responsibilities
- Maintain effective discretion and perception needed for making observations, communicating with others, reading and writing and operating assigned equipment
- Maintain mental capacity which allows the capability of making sound decisions and demonstrating intellectual capabilities
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The Quality Technician will support Pioneer’s effort to ensure our devices meet all defined design criteria, disseminate quality training, and help Pioneer achieve our overall Quality Assurance objectives.
- Conduct receiving and final inspection for all applicable products
- Support production operations in the effort to achieve optimal product quality
- Create Vision System inspection programming
- Maintain compliance with Pioneer’s Quality System and support others in this effort
- Work with quality, operations, and engineering on corrective actions related to production
- Help achieve continuous improvement to quality function
- Help transfer new designs into standard production
- Assist with first-piece-layout and in-process inspections when needed
- Contribute to engineering efforts to develop inspection criteria
- Develop and maintain SPC inspection programs
- Provide Quality leadership for second shift operations
- Strong interpersonal and communicative skills
- Detail oriented and technically competent
- Virtuous and ethical conduct (integrity, honesty, humility, etc.)
- Experience within a manufacturing environment
- Knowledge of mechanical inspection
- Machining and medical device experience a plus
- High School Diploma
- Experience within an ISO 13485 or 9001 Quality System
- Experience with mechanical inspection and metrology
- University Certificate or Degree a plus
- Machining and/or medical device experience a plus
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- Leads cross-functional project team in the development of new products
- Develops and drives planning and execution of projects by establishing and controlling development strategy, timelines, and budgets
- Schedules and conducts design reviews and other cross-functional meetings
- Initiates product evaluation with surgeons
- Generates Design History File documentation for the project
- Develops top engineering talent and motivates staff to meet deadlines
- Advanced knowledge of project management and drafting standards
- Experience with Class II medical devices
- Understanding of intellectual property (comprehending patent claims, maintaining lab notebooks)
- Familiarity with design assurance documentation
- Ability to analyze and develop new testing criteria and requirements
- Able to effectively communicate in a cross-functional team environment
- Proficiency with Microsoft Office Suite and Microsoft Project
- Knowledge of design control requirements
- Experience in minimally invasive surgery a plus
- Design Failure Modes and Effects Analysis
- Mentoring skills to develop lesser experienced engineers
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- Create CAD 3D models and concept layouts based on design criteria
- Create and maintain detailed drawings for use in fabricating prototypes and/or manufacturing production
- Process document change notices for documentation updates
- Handle multiple project tasks, manage small projects or portions of larger projects
- Participate in the design and development of new products as a key member on project team
- Interact with suppliers for prototypes, product design for manufacturability and problem solving
- Generate models and drawings to evaluate design concepts
- Create tolerance stack-up analyses
- Knowledge of CAD software and drafting standards; geometric dimensioning and tolerancing experience preferred
- Ability to analyze and develop new testing criteria and requirements
- Identify customer requirements for a new product
- Capable of performing simple statistical and engineering calculations
- B.S. in mechanical engineering, biomedical engineering, or industrial technology required.
- Experience with CAD software; SolidWorks experience preferred
- Knowledge of drafting standards
- Proficiency with Microsoft Office
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Engineer II - Product Development
Member of R&D - Fusion Products, Biomechanical engineer with full project responsibility including most activities on anew product development. Day to day activities range from design & detail solutions and focusing on bringing product to market in production volume.
- Product line authority - signature authority for documentation in an engineering capacity
- Work directly with surgeons and surgical staff in an operating room environment
- Solve surgical problems by applying engineering solutions through mechanical hardware
- Create 3-D CAD models and fully detail engineering drawings autonomously
- Correctly apply Geometric tolerancing and dimensioning to engineering drawings
- Work with suppliers to ensure products are cost effectively designed for manufacturability
- Carry out verification / validation testing to ensure product designs are safe and effective
- Work with "project" customers: surgeons, marketing staff, and technical sales force
- Drive projects internally with planning, recevingin/inspection, and distribution
- Must be proficient with 3-D modeling, detailing/drafting, manufacturing
- Bachelors degree in mechanical engineering preferred
- Minimum 6 years mechanical design or 4 years orthopedic mechanical design
- Exposure to a machine shop environment and reasonable understanding of metal fabrication
- Work experience in a regulated industry preferred
- Knowledge of CAD systems and 3-D modeling
- Knowledge of Microsoft applications
- Proficient with writing and preparing technical reports
Position is located in Austin, TX.
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Member of R&D - Fusion Products, Biomechanical engineer with full project responsibility including beginning to end activities on new product developmnet. Day to day activities range from determining project goals, design and detail solutions, commercializing product in production volume.
- Manage cross-functional team throughout the development process
- Understand/document project goals, create budgets and timelines by project
- Design history file creations and maintenance
- Product line authority - signature authority for documentation in an engineering capacity
- Work directly with surgeons and surgical staff in an operating room environment
- Solve surgical problems by applying engineering solutions through mechanical hardware
- Create 3-D CAD models and fully detail engineering drawings autonomously
- Correctly apply Geometric tolerancing and dimensioning to engineering drawings
- Identify/design QC control gages and other fabrication related hardware for project parts
- Work with suppliers to ensure products are cost effectively designed for manufacturability
- Practical experience with metallic and non-metallic materials; full understanding of material properties
- Write mechanical test protocols, test reports, and ensure product designs are safe and effective
- Work with "project" customers: surgeons, marketing staff, and technical sales force
- Drive projects internally with planning, receving/inspection, and distribution
- Must be proficient with all aspects of engineering, not just development. These proficiencies are required, including 3-D modeling, detailing/drafting, manufacturing, QC control/gage design
- This position will oversee temployrary assignment of junior engineers on a project-to-project basis and requires minimal direction from management
- Bachelors degree in mechanical or biomechanical engineering preferred
- Minimum 10 years mechanical design or 7 years orthopedic mechanical design
- Exposure to a machine shop environment and reasonable understanding of metal fabrication
- Work experience in a regulated industry required; experience with medical devices desired
- Self-starter, detail oriented, and able to work autonomously
- Knowledge of CAD systems and 3-D modeling
- Knowledge of Microsoft applications
- Proficient with writing and preparing technical reports
- Travel required, at least 1 trip per month
Position is located in Austin, TX.
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Member of R&D - Fusion Products, Biomechanical engineer with full project responsibility including beginning to end activities on new product developmnet. Day to day activities range from determining project goals, design and detail solutions, commercializing product in production volume. Engineers at this level carry multiple projects and have one or more direct reports.
- Manage intellectual property: development of patents or reviewing patents for freedom to operate
- Work with surgeons, sales adn marketing to reduce concepts into reality
- Manage cross-functional team throughout the development process
- Understand/document project goals, create budgets and timelines by project
- Design history file creations and maintenance
- Product line authority - signature authority for documentation in an engineering capacity
- Work directly with surgeons and surgical staff in an operating room environment
- Solve surgical problems by applying engineering solutions through mechanical hardware
- Create 3-D CAD models and fully detail engineering drawings autonomously
- Correctly apply Geometric tolerancing and dimensioning to engineering drawings
- Identify/design QC control gages and other fabrication related hardware for project parts
- Work with suppliers to ensure products are cost effectively designed for manufacturability
- Practical experience with metallic and non-metallic materials; full understanding of material properties
- Write mechanical test protocols, test reports, and ensure product designs are safe and effective
- Work with "project" customers: surgeons, marketing staff, and technical sales force
- Drive projects internally with planning, receving/inspection, and distribution
- Must be proficient with all aspects of engineering, not just development. These proficiencies are required, including 3-D modeling, detailing/drafting, manufacturing, QC control/gage design
- This position will have direct report(s) and will interface with those reports regularly and requires no day-to-day direction from management
- Bachelors degree in mechanical or biomechanical engineering preferred
- Minimum 15 years mechanical design or 10 years orthopedic mechanical design. At least 3 years experience directly related to spinal orthopedics is required
- Extensive exposure to machine shop environment, must understand how product is machined, cast, forged, or formed
- Work experience in a regulated industry required; experience with medical devices desired
- Self-starter, detail oriented, and able to work autonomously
- Knowledge of CAD systems, preferably Solid-Works or Pro Engineer
- Knowledge of Microsoft applications
- Must possess strong mechanical designing skills
- Proficient with writing and preparing technical reports
- Must be able to work on various projects as priorities change or directives are adjusted
- Extensive travel required, at least 1-2 trips per month
Position is located in Austin, TX.
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Success in Pioneer's team-oriented environment requires that each associate exhibit strong inter-personal skills in addition to being a leader in their respective area. Please be prepared to demonstrate past professional performances so that together we can determine if you should be on our team.
Mail or e-mail your cover letter and résumé to:
Attn: Search Director
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette, MI 49855
searchdirector@pioneersurgical.com |
