Careers

Description:
The Quality Engineer ensures the ongoing quality of TranS1 products by planning, developing, implementing and monitoring manufacturing and operational activities. Work responsibility encompasses all internal and contracted manufacturing and operational processes, as well as customer feedback and regulatory compliance and response activities.

Core Responsibilities:

• Approves suppliers, establishes commitment to TranS1-endorsed manufacturing processes and procedures, and executes monitoring activities.
• Generates and maintains process documentation (DMR’s, assembly specifications, and work instructions).
• Conducts verification and validation activities to ensure compliance with GMPs.
• Develops product quality planning to support immanent needs including, but not limited to, pFMEA, tolerance review, inspection protocol development, gage design, and sampling plans.
• Identify and recommend purchase of inspection equipment to utilize inspection resources as efficiently as possible.
• Participate in complaint investigations by verifying the result of the manufacturing process and addressing gaps where necessary.
• Trend non-conformance and quality data, and utilize the data to recommend quality improvement initiatives.
• Serves as Operations representative on Materials Review Board (MRB), recommending dispositions of non-conforming product.
• Represent Operations on new product development teams.
• Participates in risk management and process validation activities, as assigned.
• Participates in audits conducted by external agencies (FDA, Notified Body) as assigned.
• Manages the quality control function and associated inspection and technical personnel.
• Manages assigned inspection and technical personnel.

Position Requirements:
Five years progressive experience in medical device manufacturing (orthopedic implants and instruments preferred), including substantive production process support (manufacturing/process engineering) and Quality Control. Quantifiable success in improving quality via process improvements.

Strong process knowledge of a wide array of manufacturing process: Subtractive machining, injection molding, extrusion, and fill and seal medical packaging. Demonstrated knowledge of ISO 13485 and CFR Title 81 Part 820 requirements, as well as internal auditing. Experience with 3D CAD system (SolidWorks preferred). Lean/Six Sigma Green Belt Certification (or higher) and CQE designation preferred.

Description:
The Senior R&D Engineer is responsible for product design and development from concept through product launch as well as ongoing support for existing product lines. Collaborates with a wide variety of internal, customer and external groups to interpret user needs, design commercially-viable products and instrumentation, and improve upon existing technologies.

Core Responsibilities:

• Collaborates with surgeons and internal clinical and marketing groups to develop initial design inputs and to optimize prototypes.
• Utilizes 3D CAD system to create models for new designs and product manufacturing prints.
• Details designs with manufacturing engineers and vendors for manufacturability and market introduction.
• Designs and develops products and instrumentation in a manner consistent and compliant with TranS1 quality standards and related FDA/ISO criteria.
• Define validation requirements and required mechanical testing.
• Provides technical support for product launches.
• Serves as a technical resource for surgeons and sales & marketing groups for existing technologies.
• As assigned, represents engineering interests in anticipated business relationships and technology evaluation.
• Participates in the definition of new project objectives.
• Attends surgeries and clinical labs as needed to support product development initiatives.

Position Requirements:
BS in Mechanical Engineering, Biomedical Engineering or similar discipline with medical device experience; Master Degree preferred. Minimum of 5 years orthopedic or spinal implant device and instrumentation development experience. Preferred background includes project management for multi-disciplinary teams (quality, regulatory, manufacturing, marketing and suppliers).

Competent with MS Office Professional suite (including MS Project) and 3D CAD systems (Solidworks preferred). Professional-level oral and written communicator with strong relational skills. Working knowledge and understanding of FDA QSR and ISO requirements related to medical devices.

Description:
The R&D Engineer is responsible for product design and development from concept through product launch as well as ongoing support for existing product lines. Collaborates with a wide variety of internal, customer and external groups to interpret user needs, design commercially-viable products and instrumentation, and improve upon existing technologies.

Core Responsibilities:

• Participates in all phases of product development in collaboration with clinical, marketing and regulatory groups.
• Utilizes 3D CAD system to create models for new designs and product manufacturing prints.
• Details designs with manufacturing engineers and vendors for manufacturability and market introduction.
• Designs and develops products and instrumentation in a manner consistent and compliant with TranS1 quality standards and related FDA/ISO criteria.
• Defines validation requirements and required mechanical testing.
• Conducts bench testing and prepares associated documentation in support of verification/validation activities.
• Provides technical support for existing product lines.
• Serves as a technical resource for surgeons and sales & marketing groups for existing technologies.
• Participates in the definition of new project objectives.
• Attends surgeries and clinical labs as needed to support product support initiatives.

Position Requirements:
BS in Mechanical Engineering. Minimum of 2 years design engineering experience in a regulated and ISO-governed environment, including project management with a multi-disciplinary team. Medical device design experience is preferred.

Competent with MS Office Professional suite (including MS Project) and 3D CAD systems (Solidworks preferred). Effective oral and written communicator with demonstrated relational skills. Working knowledge of ISO requirements.