Project Engineer
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:
- Leads and/or participates in project teams for the design and development of medical devices.
- Develops and maintains Design History Files in accordance with client procedures and regulations
- Interfaces with clients to define and achieve design objectives
- Proactively works with all parties throughout the product development lifecycle to successfully achieve milestones
- Interfaces with quality, operations, and external vendors to ensure manufactured products meet design intent
- Compiles, prepares, and presents information for project updates and technical presentations
- Assists in resolving complex engineering problems and providing sound solutions to clients
Qualifications:
- Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline
- Minimum 4 years of related work experience in the medical device industry (spine/orthopedic experience preferred)
- Extensive 2D/3D CAD design experience in Solidworks, Siemens NX, or similar software
- Experience with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 and designing components for manufacturability
- Ability to coordinate the manufacturing of design prototypes and production parts with external vendors
- Familiarity with verification and validation testing of medical devices
- FEA (Finite Element Analysis) experience a plus
- Experience designing products in a regulated environment including FDA, EU/MDR, ISO, and other relevant regulations
- Understanding of the phases of medical device development in accordance with regulations and industry standard practices
- Excellent interpersonal and written communication skills
- Ability to multitask and efficiently manage multiple projects
- Candidate must be a self-starter, self-motivated, and results-oriented
- Able to work both independently and have with cross-functional teams
- Extensive project management skills with the ability to work against tight timelines
This position will involve all aspects of product design and project management including, but not limited to, client consultation, vendor selection and management, marketing support, and post-market surveillance.
Benefits of Employment:
- Competitive Base Salary plus Bonus potential
- Benefits: Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO, 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule, remote work from home days
- Company cell phone and laptop
- Training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems
- Exciting, fast-paced, and team-oriented culture with fun company outings and team building activities
- Great opportunity to get in on a growing, enthusiastic company and establish yourself as a long-term key member
Quality and Regulatory Engineer
We are currently seeking a self-motivated, charismatic individual to join our regulatory and quality 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:
- Identifies regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards
- Prepares premarket FDA, and international regulatory submissions, with technical review of data and reports
- Communicates with regulatory agencies via pre-submissions and responses to premarket submission requests
- Development and/or revision of Quality System procedures and processes
- 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
- 2+ years’ related work 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
- Direct experience working on processes within a Quality System (ex. CAPAs, complaint management, document controls, supplier controls)
- 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 with high attention to detail in written work
- Must be able to work independently and have ability to work with cross-functional internal and external teams
- Extensive project management skills with the ability to work under tight timelines and able to multi-task
- Interest in taking on new challenges and expanding quality/regulatory skillset through on-the-job training and experience
This position involves all aspects of Regulatory and Quality, including customer consultation, marketing support, design and development support, and post launch surveillance for our customers.
Benefits of Employment:
- Competitive Base Salary plus Bonus potential
- Benefits: Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO and 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule including remote work from home days
- Company cell phone and laptop
- Training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems
- Exciting, fast-paced, and team-oriented culture with fun company outings and team building activities
- Great opportunity to get in on a growing, enthusiastic company and establish yourself as a long-term key member