We're Hiring!

 

Our open roles are listed below. If you’re interested in working with us, please send your resume and cover letter to [email protected].

Role:

We are currently seeking a self-motivated, charismatic individual to join our product development engineering team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we’d love to hear from you!  

Essential Responsibilities:

  • Project leader for the design and development of medical devices
  • Interface with clients to define and achieve design objectives
  • Proactively work with all parties throughout the product development lifecycle to successfully and achieve milestones
  • Interface with quality, operations, and vendors to ensure manufactured products meet design intent
  • Create and maintain device history files per FDA, ISO and other regulations
  • Compile, prepare and present information for project updates and technical presentations
  • Assist in resolving complex engineering problems and provide sound solutions to clients

Qualifications:

  • Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline
  • 7-10 years related work experience in the medical device industry
  • Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability
  • Ability to coordinate the manufacturing of design prototypes and production parts
  • FEA (Finite Element Analysis) experience a plus
  • Experience designing products in a regulated environment including FDA, ISO and other regulations
  • Understand and navigate through the multiple Phases of product development, including, design, manufacturing, verification, and validation
  • Excellent interpersonal and written communication skills
  • Ability to simultaneously manage multiple projects efficiently
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

This position will involve all aspects of product design and project management including customer consultation, vendor selection and management, marketing support and post launch surveillance.

Role:

We are currently seeking a self-motivated, charismatic individual to join our regulatory affairs team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we’d love to hear from you!

Essential Responsibilities:

  • Assist with regulatory pathways and strategies, premarket FDA, and international regulatory submissions
  • Support post-market surveillance activities and regulatory requirements
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised regulations

Qualifications:

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 5-7 years’ related work experience in the medical device or regulated industry
  • Working knowledge of FDA and other regulatory authorities
  • Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
  • FDA regulatory submission experience (Pre-Submission, 510ks, De Novo, IDEs)
  • International submission experience a plus
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

This position involves all aspects of Regulatory Affairs, including customer consultation, marketing support, design and development support, and post launch surveillance for our customers.

 

Essential Responsibilities:

  • Assist with development and/or revision of Quality System procedures and processes.
  • Assist with internal and supplier audit development, implementation, and execution
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

Qualifications:

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 5-10 years’ experience in the medical device industry
  • Working knowledge of FDA and other regulatory authorities
  • FDA Regulatory submission experience (Pre-Submission, 510ks, PMAs, IDEs)
  • International submission experience a plus
  • Quality Systems development, implementation, and training experience
  • Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task5