Director Design Controls/Engineering Process Improvement

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

Because while we may not be at a patient's bedside, their health is still in our hands.

The Director, Design Controls / Engineering Process Improvement is a highly motivated, technically savvy, team builder, capable of guiding the R&D community to a regulatory compliant high performance organization. This position has broad responsibility to guide all global engineering departments through the journey of constant process improvement to ensure compliance to world wide regulatory requirements creating high performance state of the art processes in all aspects of product development. This position will engage with remote sites in optimizing the coordination of engineering activities as they relate to compliance to Design Controls and process improvements that improve the velocity of development.

A proven track record of success in medical device development is required. Responsibilities routine auditing of projects for conformance to established SOPs, driving improvements to SOP to improve velocity, conformance and conducting training programs were appropriate. This position works closely with the Program Management Office and assists their efforts were appropriate. They have a broad reach to advise teams (Hardware, Software, Verification, Validation) in the efficient and compliant execution of all elements of Design Controls. Occasional travel to remote locations is required.

This hybrid position is located in Snoqualmie, WA and requires 3+ days per week for onsite collaboration.

• Assesses current SOPs as they relate to Design Controls, makes recommendations for process improvements and assembles teams in coordinating SOP updates that improve regulatory compliance and efficiencies.
• Program manages remediation project for existing product to bring them into compliance for new Design Control SOPs.
• Advises the CTO on process improvement activities directed towards constant movement towards high performance, high velocity, regulatory compliant teams.
• Presents to executive leadership progress on continuous improvement status.
• Participates as an independent review in design reviews.
• Audits project deliverables as they relate to conformance to Design Controls
• Assist the Sr Director of Engineering in Snoqualmie in support of remove teams under their direction.
• Development processes and metrics that effectively measure and improve team performance.
• Ensures that engineering professionals are fully competent for their roles, that they are effectively organized to deliver service to users, and that they receive appropriate training and mentoring.
• Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the Company's Code of Ethics and Conduct.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor of Science in engineering or equivalent with a minimum of 10+ years of medical product development experience. Advanced degree or MBA is preferred.
• Minimum of 5 years prior engineering development experience as an individual contributor in medical device design or development organization.
• Minimum of 5 yrs experience managing cross functional medical device teams.
• Minimum of 1 year experience working with remote international development teams.
• Project Management Professional (PMP) certification.
• Must have a full understanding of FDA Design Controls, Quality System Regulations, ISO 13485, ISO 14971, MDSAP, and EU MDR requirements.
• Must have experience managing remote development activities. This role is global and will require development and support of communication and relationships with sites outside team.
• Must be comfortable and effective acting as a catalyst for change. Experience in an environment with high regulatory scrutiny and high rates of continuous improvement activity is preferred. Experience and ability to contribute to Spacelabs' continuous improvement plans as a senior leader is preferred.
• Strong interpersonal skills, excellent formal and informal communication skills, innovative problem solving skills and strong facilitation skills are required to ensure the unique needs of the ADV business are understood and addressed cross functionally within Spacelabs.
• Candidate must be assertive, willingly take responsibility for performance and results, and able to motivate and lead strong teams towards overcoming obstacles to achieve product development goals.

#LI-Hybrid

Please review our benefits here: Life at OSI

The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

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Poster Link: https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_self_print_poster.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.