Hologic Manager, Design Assurance in Marlborough, Massachusetts
Manager, Design Assurance
Post Date Jun 14, 2018
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
Provide tactical support for the Design Assurance team; this includes managing Design Assurance engineers on the team through goal setting, project resourcing and guidance for product support. Additionally evaluate procedures/processes for potential improvement and initiate collaborative relationships. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
Essential Duties & Responsibilities
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Manages the Design Assurance team through direction of activities, establishment of goals and objectives, definition of expected performance, provision of daily support and regular feedback regarding execution. Work with team members to support individual development plans. This role may include budget responsibility.
Provides guidance to Design Assurance Engineers regarding design control compliance requirements including assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met and assuring risk management is reflective of current standards and inclusive of all required elements.
Provides guidance to Design Assurance Engineers regarding technical and project based issues. Assist with development of solutions and approaches to successful alignment with teams.
Participate in resource planning and management for new product development, sustaining product support, and sustaining projects. This includes working with divisional program management team, manufacturing sites teams and design assurance team to assure projects are clearly scoped, allocations are appropriate and work is aligned with divisional and company priorities.
Participate in on-going product/project support activities including, but not limited to:
Sustaining project management (charter reviews, resourcing, timeliness, compliance)
Complaint review board (evaluation of trends, identification of high risk concerns, initiation of CAPAs)
Real-time aging review board (periodic review of test status, test results)
Design review committee member (technical oversight of projects)
Has or acquires expertise on compliance issues and current/upcoming expectations of regulatory agencies and industry best practices. Uses expertise to provide guidance to project teams/divisions to assure appropriate compliance. Works collaboratively with Regulatory team, R&D team and others impacted to assure successful implementation/integration of new requirements.
Coordinates improvements to established procedures and initiates new procedures, as needed, which affect product development, design changes, and verification and validation activities.
Responsible for oversight of Health Risk Assessments when a HRA is needed for evaluation of on market product to assure the team has documented an efficient and effective analysis of situation, including problem definition and impact.
Participate as needed on new product development project and sustaining product projects including assessing change requests of product for impact to design, determine supporting information required for implementation of changes.
Technical Bachelor Degree
8 plus years’ experience preferably in medical device industry
Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
Experienced with ISO 14970, IEC60601, IEC62366, and EN62304
Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
Strong working knowledge of verification and validation requirements for a regulated product and requirements analysis, including development of testable and measurable specifications
Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment
(Managerial and Interpersonal)
Ability to effectively manage individual contributors of varying experience each with multiple products and projects to support.
Experience with multi source demands for project and product support, ability to coordinate and provide an effective team environment.
Ability to determine when to take leadership role on critical tasks to assure appropriate and timely completion/resolution and when it is better suited to provide guidance to team
Familiarity with employee development and mentoring process
Demonstrates independent decision making and prioritization, including independent resolution of conflicts
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.