Job Purpose 

The Manufacturing Engineer is responsible for providing manufacturing engineering services to support efficient manufacturing processes. Come be part of a truly collaborative culture where you’ll learn from industry experts about building a team, leadership, manufacturing, and how to grow a company. 

Duties and Responsibilities   

• Maintain and improve controlled technical documents such as prints, procedures, bill of materials and routers.  

• Support a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.  

• Create manufacturing lines from the ground up including creation and documentation of manufacturing assembly fixtures.  

• Improve process methods which meet performance and quality requirements.  

• Execute project plans and schedules for acquisitions, CAPAs, improvement, various engineering projects, and process flow projects, not limited to just the shop floor.  

• Communicate (written and verbal) with appropriate personnel from other departments.  

• Partner with cross-functional departments to make process and procedure recommendations.  

• Establish full protocols for clean room environment and maintain required inspection and documentation.  

• Learn and implement lean manufacturing techniques.  

• Develop an understanding of problem-solving methods and learn to lead kaizen events.  

• Support process and product validations, incoming inspection, end of line quality controls, and packaging, including but not limited to IQ, OQ, PQ. 

Qualifications and Skills 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills, and abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. 

• A minimum of a Bachelor of Science Degree in an Engineering discipline is required.  

• A minimum of 1 year of industry experience in an Engineering role is required.  

• CAD experience (Solidworks, Pro-E/Creo, AutoCAD). Preferred use in Solid Works.  

• Ability to balance quality, compliance, and safety to meet customer requirements.  

• Ability to independently handle and prioritize multiple medium complexity project assignments and complete work in a timely manner.  

• Good problem-solving skills using quality and statistical tools.  

• Demonstrates good written and verbal communication skills.  

• Microsoft Office Suite and MS Project.  

• Demonstrated ability to take initiative and provide recommendations on process, procedure, and training.  

 Working conditions  

• This is a Salaried, exempt position that will require occasional evening work, correspondence with customers, distributors, and regulatory bodies outside of normal working hours.  

• Travel not to exceed 20%  

• Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment  

• Must successfully pass background screening and drug screening  

Physical requirements  

• A candidate may need to occasionally push, pull, or lift 25-50 lbs.  

• Frequent walking, standing, or sitting for extended periods of time.  

To Apply  

Please submit your resume to careers@c2dx.com. 

Job Purpose

The Regulatory Affairs Manager C2Dx is a leadership position contributing significantly to the Quality Assurance and Regulatory team. In this role, you will be a critical team member contributing to the execution of the company strategy and Quality Management System (QMS) for an evolving medical device company. This role will provide Regulatory Affairs leadership with significant time spent managing product regulatory strategy, licensing, market authorization, and registration tasks and documents and maintaining regulatory filing documents required by various countries and jurisdictions. You will be expected to work alongside cross-functional management teams and support our products, services, and Quality System.

Duties and responsibilities

To be successful in this role, an individual must be able to perform the following satisfactorily; other duties may be assigned.

• Understand and perform duties and responsibilities according to the C2Dx QMS
• Lead and execute regulatory strategies to protect and enhance profitability
• Develop, implement, maintain, and improve regulatory processes ensuring compliance with all applicable regulatory requirements
• Provide regulatory leadership on new product registrations, modified/enhanced products, transferred products, and acquisition activities
• Perform and/or direct coordination and preparation/submission of any/all documents for regulatory submissions, inspection responses, and regulatory agency notifications when required
• Provide direction and coaching to specialists to meet regulatory requirements as scheduled and resolve technical or operational issues
• Collaborate with external regulatory authorities, competent authorities, authorized representatives/sponsors, importers/distributors, and notified bodies partnering with cross-functional stakeholders to ensure alignment and effective execution of regulatory strategy to achieve business objectives
• Lead interactions with regulatory agencies as part of strategy development and support of regulatory application and document reviews
• Provide guidance to all team members on regulatory requirements for planning and contingencies ensuring compliance with all applicable regulations
• Provide status reports to executive management
• Support internal quality and external regulatory authority or notified body audits as required
• Perform regulatory review and approval of product and manufacturing changes for compliance with applicable regulations when required
• Continually provide and contribute towards company and process improvements to the C2Dx QMS        Qualifications

Qualifications include:

• Bachelor’s degree in an engineering, healthcare, or scientific field with 3-5+ years of relevant experience is required
• Prior experience within regulatory affairs in healthcare, medical device, or pharmaceutical industry is required
• Prior experience in managing regulatory projects with multi-national regulations and agencies experience is preferred
• Master’s degree or relevant certifications is a plus

Working conditions  

• This is a Salaried, exempt position that will require occasional evening work, correspondence with customers, distributors, and regulatory bodies outside of normal working hours.  

• Travel not to exceed 20%  

• Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment  

• Must successfully pass background screening and drug screening  

Physical requirements  

• A candidate may need to occasionally push, pull, or lift 25-50 lbs.  

• Frequent walking, standing, or sitting for extended periods of time.  

To Apply  

Please submit your resume to careers@c2dx.com.