Current Opportunities

Design Assurance Engineer

The Design Assurance Engineer will work as a member of the Engineering project teams in New Product Development and Sustaining Engineering in the development and maintenance of Design History Files, necessary design control documentation and regulatory compliance for medical devices.

This individual has joint responsibility for the design and development plan with the overall project leader and helps project teams deliver complex medical device projects on time with the highest quality and product safety. They will ensure that design control requirements as defined by all relevant company SOPs are adhered to, and that safety and efficacy are demonstrated. At all times throughout the process, they will identify and mitigate risks. They will also work with regulatory bodies to ensure products meet the necessary standards as well as work with the entire organization on regulatory clearance for new geographical areas, features and product lines.

Key Responsibilities May Include:

  • Provide support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
  • Ensure compilation and maintenance of product Design History Files.
  • Partner with R&D engineers and Sustaining Engineering to ensure design reviews are thorough and robust.
  • Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
  • Ensure documentation of traceability of requirements through design output and to design verification and/or design validation.
  • Drive project teams towards early requirements maturation, early test plan/script development, and design input requirements that are indicative of real-world use case environment and customer needs.
  • Participate in cross-functional reviews to analyze, prioritize and disposition design defects (including software anomalies).
  • Review intended use validation for non-product software and tools used in the development process.
  • Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
  • Support the CAPA process by performing investigation, root cause analysis and verification of effectiveness checks for design related issues.
  • Support internal and external regulatory and customer audits.
  • Participate in the improvement of the manufacturing process for existing products as needed.
  • Lead regulatory efforts for product clearances both within the US and outside the US.
  • Review and approve work instructions, inspection documents, Bills of Material and drawings as needed.

Qualifications:

  • Bachelor’s Degree in engineering or related field is required.
  • 5+ years’ experience in medical in a design/development.
  • Knowledge and experience with complex multifunctional systems is required.
  • Strong, demonstrated ability to interact closely on technical terms with R&D personnel is required.
  • Strong ability to facilitate cross-functional team meetings and the ability to drive project teams towards strong product quality, safety and compliance is required.
  • Detail oriented with strong organizational and record keeping skills is required.
  • Strong advocate of process and accountability and not afraid to challenge when necessary.
  • Strong problem solving and root cause analysis skills is required.
  • Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485 product realization is required.
  • Strong written and oral communications skills using English language is required; ability to succinctly and clearly describe complex issues in meaningful ways is required.
  • Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts is required.
  • Demonstrated ability in being proactive and timely in execution of assigned tasks is required.
  • Ability to be flexible and adaptable to changing priorities is required.
  • Experience with 510K and EU CE clearances is preferred.

 

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Director, Engineering

Authorized to work in the US

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Technical Product Manager

The Technical Product Manager provides support, training, and communications to service and support teams for Surround Medical Systems products. The primary focus of this position is on serviceability, product documentation and knowledge base management. It is accomplished through working relationships across functional teams within Engineering, Manufacturing, Customer Support and Quality Assurance.

Duties will include:

  • Provide 2nd tier technical support to internal and external customer facing teams via phone and electronic communication.
  • Develop and maintain service documentation including service manuals, field service advisories and technical service bulletins.
  • Create and deliver instrument specific technical training to customer facing teams.
  • Monitor product performance and service delivery thru the product life cycle
  • Work closely with cross functional teams (Engineering, Manufacturing and Quality Assurance) to provide service input and expertise.
  • Develop processes and tools as required to positively impact service delivery.

Experience,  Education and Skills:

  • Bachelor’s Degree Preferred
  • 2+ years Engineering Role Preferred
  • Technical Training/Technical Writing experience a plus
  • Excellent verbal and written communication skills; good interpersonal/customer relations skills.

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Director, Service Operations

Authorized to work in the US

APPLY HERE
Director of Service Operations

DIRECTOR – SERVICE OPERATIONS

Position Summary:

The Director of Service Operations is responsible for coordinating the installation, maintenance and warrantee claims of the Surround Medical Systems.  Responsible for building and maintaining Service Operations department for Surround Medical. Responsible for the Service Department’s resource planning, hiring, and budget. Coordinates and organizes all necessary resources of a third-party installation and service provider and manages customer support service and service field operation resources to meet commitments.  Oversees the implementation of medical systems, supports multiple implementation projects, reviews customer product demands, develops project plans and ensures that implementations are completed on time, within budget, and meet customer and business expectations.

Key Duties and Responsibilities:

  • Coordinates with third party service providor all system installation and field service activities. Develops installation templates, defines time-lines and identifies task owners.  Interacts with the appropriate Field, Manufacturing, Engineering, Supply Chain and Home-office personnel to ensure completeness of installation plans and activities.  Communicates and distributes installation information to all affected individuals.  Tracks and drives completion of tasks, and alerts/escalates potential failures to appropriate management personnel.
  • Acts as point-of-contact for the field service and customer regarding status of installation timelines and real-time product ship information. Acts as facilitator and point-of-contact for cross-functional teams created to assist with product installations.
  • Key point of contact to understand issues with new installations and technical escalations to ensure functional support areas are properly engaged through resolution.
  • Tracks products per 21CFR requirements and ensures full traceability for customer systems and replacement parts. Adheres to strict guidelines for adverse events and reporting per 21CFR requirements.
  • Quickly addresses customer concerns and questions with exceptional follow up and responses.
  • Monitors schedule completion identifies shortfalls and tracks through completion
  • Utilizing automated tools creates, monitors and reports a series of metrics with respect to all service deliverables. These metrics are used to improve overall team performance, determine areas of opportunity and adhere to FDA requirments.
  • Contributes to team efforts by accomplishing related results in a cooperative and supportive manner.

Education Qualifications:

  • Bachelor’s degree or greater

Training and Skills:

  • 5+ years in service operations management
  • Medical device service/installation experience preferred.
  • Excellent verbal and written communication skills; good presentation skills; good interpersonal/customer relations skills.
  • Familiar with Service Cloud or similar management software
  • Familiar with Propel or similar document management software
  • Excellent analytical, planning, organizational, and project management skills; receptive and supportive of team efforts.
  • Ability to persuade/influence others in sensitive/confrontational situations.

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Senior Vice President

Authorized to work in the US

APPLY HERE