Director, Compliance Engineering - Remote

Company: Kinsley Power Systems
Location: Schaumburg
Posted on: September 16, 2020

Job Description:

Director, Compliance Engineering - Remote Requisition ID 10096 Global Function R&D Engineering Location USA, Illinois, Schaumburg

If you are looking for a challenging opportunity to work in an international environment, then we may have a job for you. We are looking for a Director of Compliance Engineering to create, lead, and execute the strategy for compliance within our global R&D organization.

Welcome to Natus Medical Incorporated

We’re the leading manufacturer of medical devices and software for a range of specialties, including Newborn Care, Neurology, Sleep, Hearing and Balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our products help improve the lives of people from birth to 100+.

The success of our company depends on our employees. This is where you come in.

The Director of Compliance Engineering is a senior leader within our global R&D organization who ensures activities and deliverables of the R&D team adhere to Natus Design Controls and the relevant Quality, ISO and Regulatory Standards. You can expect to apply deep knowledge of design controls and global regulations such as US FDA CFR 820 and EU MDR. As a leader, you can expect to coordinate the activities and training of the R&D team to ensure that the design documentation is compliant to regulations. You’ll provide hands-on leadership for various projects including NPI, Maintenance, Sustaining, DHF Remediation, and CAPAs to ensure the R&D team is set up for success.

Here’s what you can expect:

Comprehensive benefit package that starts on your 1st day

401k Match

Employee stock purchase plan

9 paid holidays

Generous paid time off plan (4 weeks to start)

Tuition reimbursement up to $5,000 annually

About the Team:

You can expect to build and grow a team of up to 10 direct reports (R&D Quality Engineers) who will work on various R&D projects with project teams. You can expect to provide indirect/matrixed supervision to the entire R&D team as it relates to compliance and design controls.

Main Responsibilities

Drive the R&D Compliance Strategy for the entire Natus Product families against the regulations and regulatory changes including but not limited to US FDA CFR 820, EU MDR, Risk Management, Bio-Compatibility, Usability Engineering, Mobile Applications/Cloud and IoT

Drive cross functional alignment between R&D, QA, RA, Product Management and Operations leadership to ensure Natus has “one common understanding” of the regulations, regulatory changes, directives and guidance

Disseminate the ever changing regulatory landscape to appropriate and necessary updates to Natus Design Control Procedures and Work Instructions. Works with Systems Engineering Manager and QA Manager to drive these procedural changes and appropriate implementation timing

Perform assessment of Natus products against the regulations/changes to regulations (US FDA, EU MDR, CFDA, ISO and IEC) and provides a strategy and roadmap for DHF Remediation, TDF Remediation and Product Remediation

Build and mentor a team of R&D Quality Engineers whose primary responsibility is to ensure that the design documentation produced by the R&D project team is of high quality and compliant to Natus Design Control procedures

Take ownership of the Remediation project strategy and provides the compliance supervision to the project teams to ensure a cross functional alignment on deliverables and execution strategy

Provide or coordinate in-class and hand-on training to the R&D project team members (both internal and off-shore/on-shore external contractors)

Work closely with the R&D Functional Managers to ensure that all Natus R&D teams (Hardware, Systems, Software, Verification, Validation, Sustaining, PMO and Labelling) are familiar with, trained on and follow all Design Control and Compliance procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation

Attend all external audits (FDA, MDSAP etc) and provides the necessary support by working closely with Systems Manager, other R&D Managers and Design SMEs

Create key performance indicators (KPI) to assess R&D projects and CAPA execution as it relates to compliance procedures and design controls ; Uses KPIs to make continuous process improvements with R&D

Travel: up to 50% domestic or international travel

Qualifications

Bachelor’s degree in Engineering, Life Sciences or related discipline required; Master’s degree preferred

10+ years’ experience of successful demonstrated experience leading Compliance Engineering, Quality Assurance/Quality Engineering or Regulatory Affairs within medical device/diagnostics industry

Proven deep knowledge and successful application of following regulations and standards -- FDA Quality System Regulations CFR 820, EU MDR 2017/745, Design Controls, Current Good Manufacturing Practices, ISO 13485, ISO 14971, EN 62304, IEC 60601, IEC 62366, ISO 10993

Ability to understand and evaluate complex data and regulations and communicate compliance risks with clarity and integrity

Superior communication, collaboration and negotiating skills. Ability to achieve buy-in and understanding across different functional areas within the company and influence the senior leadership team and the rest of the organization

Effective communication skills, superior written communication and presentation skills

Extensive experience working with global teams and offshore partners

Demonstrated strong sense of urgency and ability to manage conflicts

PMP certification preferred, but not required

EEO Statement

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

Keywords: Kinsley Power Systems, Schaumburg , Director, Compliance Engineering - Remote, Other , Schaumburg, Illinois