JOIN OUR TEAM
A Career That Matters With A Company Who Makes a Difference
Whether you’re a professional seeking greater challenge or a student embarking on an exciting new career, BionX™ has opportunities for you. You provide the talent, energy, and desire to be part of a company that improves the quality of life for people around the world. We’ll provide all the best tools, from ample training to a comfortable and state-of-the art workplace. If you’re ready to make a difference, then we’d like to hear from you. We invite you to explore the many career opportunities available. BionX offers competitive salaries and benefits, including medical insurance and dental, retirement savings, income protection, training, and much more.
We look forward to hearing from you.
BionX is an equal opportunity employer.
Please submit resumes to: email@example.com
Manufacturing / Quality Engineer
Responsible for the development and implementation of manufacturing processes, which ensure all medical devices meet specification.
Participate in supplier quality and quality control functions, including: supplier assessment/audits and resulting corrective actions, and establishing quality inspection criteria for incoming parts.
Participate and provide leadership in compliance and continuous quality improvement.
Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.
- Ensure all manufacturing documentation is adequate and complete. Manage engineering change process related to manufacturing specifications and equipment.
- Provide technical support, troubleshooting and guidance to production areas including process and test development and problem resolution working under minimal supervision.
- Design and conduct manufacturing related qualifications and validations; ensure all processes are properly validated prior to production.
- Interface with design engineering and production to effect product design changes and to introduce new products to manufacturing.
- Identify areas where equipment and process improvements will positively affect production methods and quality. Conduct data collection and analysis of field population data
- Review and evaluate minor engineering changes and/or other specification requirements.
- Performs supplier audits and assessments, and follows corrective Actions through to completion. Establishes and implements QC inspection criteria.
- Perform internal audits of the Quality System
- Participate in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes Analysis
- Monitor manufacturing of assigned products, assuring compliance with DMR and assuring complete and correct Device History Records are maintained
- Other duties as required.
- Bachelor’s Degree in Electrical/Mechanical or Manufacturing Engineering or equivalent education and/or experience.
- 5+ years related experience.
- Thorough knowledge of FDA Quality System Regulations and ISO Quality Stems Requirements.
- Familiarity with SPC, Experimental Design and Statistical Sampling Techniques.
- Ability to work independently and in team Environment
- Ability to effectively communicate written and verbally
- Other skills: Root cause analysis experience, technical understanding of electro-mechanical devices, process improvement techniques
Territory Sales Manager
Manage a particular region of the US and sell emPOWER & BiOM products to consistently meet sales quotas. Responsible for selling the company’s medical devices and developing sales strategies based on company Goals.
- Consistently meet or exceed all sales goals; Responsible for the sale of the company’s products within an assigned territory or geographic region;
- Position the emPOWER technology to facilities and Healthcare Professionals in designated area;
- Calls on prosthetists, physicians, hospitals, Worker’s Compensation providers, clinics, Amputee Support Groups, and other organizations that require medical device products that focus on Patient care. Incumbent may be responsible for both existing and new accounts;
- Coordinate CEU presentations with advocate and advisor Groups;
- Provide patient outcome feedback to Adjusters and Physicians;
- Identify applicable candidates for the emPOWER technology, monitor product usage;
- Complies with applicable laws in providing physicians with literature;
- Provides expertise and customer service to accounts;
- Provides technical expertise to clients regarding company’s products and services;
- Submit weekly call reports, field activity reports, and ankle delivery data in a timely manner;
- Gathers data on marketing trends and competitive products and pricing;
- Builds relationships with customers to influence the acceptance and use of company’s products;
- Other duties as required.
- Requires a BA/BS or 2-4 years medical sales experience that provides knowledge and exposure to fundamental theories, principles and concepts. Previous experience selling Orthopedic products preferred as well as understanding of medical reimbursement;
- Ability to manage a territory with limited supervision. Receives instruction, guidance and direction from others and may require co-travel and customer introductions
- May be a new territory with no expectations of relationships. Target account plan provided. No supervisory responsibilities; accountable for developing technical/functional contribution.
- Requires conceptual knowledge of theories, practices and procedures within medical device industry
- Applies general knowledge of business developed through education or past experience.
- Exchanges straightforward information, asks questions and checks for understanding.
- Requires ability to get to all customers’ operations and facilities via air, own automobile and local Transport.
- Requires the ability to meet deadlines, frequent assignment changes, periodic heavy workload, rapidly changing technology and dynamic business growth.
- Requires domestic travel 50-75% of the time. Requires mobility at conventions and Meetings.
Principal Mechanical Engineer
The ideal candidate will be a systems engineer or a robotics engineer, with the strongest discipline being Mechanical Engineering.
- Design mechanical systems and subsystems. Perform 3D modeling, simulation, and analysis;
- Design for safety, manufacturability, reliability and test in accordance with international standards such as ISO 14971 and IEC60601-1;
- System test and debug;
- Design verification and Validation;
- Support manufacturing and test;
- Participate in risk management and control: Perform Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA);
- Participate in design reviews and document development activities per established product development standard operating procedures;
- Mentor junior engineers;
- Other duties as required.
- BS in Mechanical Engineering required. Advanced degree(s) a plus.
- 12+ years of experience in an engineering environment. Medical product design preferred.
- Methodical, detail oriented, and well organized.
- Additional work showing versatility in other disciplines is highly desired.
- Knowledge of regulatory and compliance requirements for medical and commercial products is a must as is experience producing compliant design control documentation.
- Experience with robotic or other complex electromechanical systems is strongly desired.
- Demonstrated track record of exceptional individual performance in a fast paced environment.
- Strong interpersonal skills. Thrives in highly integrated team Environments.