Electrophysiology Systems Design Assurance Director
4 weeks ago
About the Role:
The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our design sites, leading a cross-functional product development team to design and maintain world-class Electrophysiology Systems. This is an exciting opportunity to lead a team in developing and sustaining medical electrical equipment/systems (MEE) and developing a strong System of System Organization focus on building expertise in IEC 60601, Cybersecurity and Reliability and other related topics.
Key Responsibilities:
• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
• Develop and execute organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.).
• Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects.
• Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Own and drive commercial product monitoring and all related product sustainment activities.
• Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
• Directly interface with internal and external audit activities.
Requirements:
• Minimum of a Bachelor's degree
• Minimum of 10 years of related experience
• Minimum of 5 years of direct or indirect management experience
• Regulatory compliance experience in the areas of medical devices
• Preferred Qualifications: Advanced degree in technical fields, experience leading technical teams, prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience.
About Boston Scientific:
Boston Scientific is a global medical technology leader that shapes medical innovation for life. We develop medical solutions that improve patient lives. We are passionate about making a meaningful difference in people's lives. At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
-
Waltham, Massachusetts, United States Boston Scientific Full timeAbout the Role:The Design Assurance Director is a key leadership position responsible for ensuring the quality and compliance of Electrophysiology Systems. As the Site Head of Quality, this individual will oversee the quality assurance process for the Pulse Field Ablation Franchise, working closely with cross-functional teams to design and maintain...
-
Design Assurance Director
4 weeks ago
Waltham, Massachusetts, United States Boston Scientific Full timeJob SummaryBoston Scientific is seeking a highly skilled Design Assurance Director to lead our Electrophysiology Systems team. As a key member of our organization, you will be responsible for ensuring product quality and compliance through the application of Design Control and Risk Management.Key ResponsibilitiesLead quality team on product/system...
-
Design Assurance Director
4 weeks ago
Waltham, Massachusetts, United States Boston Scientific Full timeAbout the Role:The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having a direct interaction with Montreal, Heredia and Arden Hills sites.This is an exciting...
-
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionThe Director of Clinical Quality Assurance and Pharmacovigilance is a senior leadership position responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations. This role is responsible for developing and implementing strategies...
-
Product Design Director
4 weeks ago
Waltham, Massachusetts, United States Constant Contact Full timeJob Title: Director, Product DesignAbout the Role:We are seeking a highly skilled and experienced Director of Product Design to lead our product experience design team. As a key member of our leadership team, you will be responsible for delivering business objectives through the creation of superior user experiences for our clients and internal team...
-
Program Medical Director
4 weeks ago
Waltham, Massachusetts, United States Spectrum Health Systems Full timeJob Summary:Spectrum Health Systems seeks a highly qualified Medical Director to lead our substance abuse treatment program. The ideal candidate will have a strong background in mental health, a master's degree in a related field, and a minimum of three years of experience in a behavioral health program.Key Responsibilities:Supervise the implementation and...
-
Clinical Program Director
4 weeks ago
Waltham, Massachusetts, United States Spectrum Health Systems Full timeJob SummarySpectrum Health Systems is seeking a highly skilled Clinical Program Director to oversee the day-to-day operations of a substance abuse treatment program. The ideal candidate will have a strong background in clinical services, leadership, and program management.Key ResponsibilitiesSupervise the implementation and delivery of clinical and case...
-
Regulatory Operations Director
4 weeks ago
Waltham, Massachusetts, United States Syndax Pharmaceuticals Full timeAbout the Role:Syndax Pharmaceuticals is seeking an Executive Director, Regulatory Operations to formulate and implement a regulatory operations vision and strategy for a commercial stage biotechnology company.The ideal candidate will be responsible for envisioning and implementing a fit-for-purpose Regulatory Information Management (RIM) system across...
-
Human Resources Director
4 weeks ago
Waltham, Massachusetts, United States Atlas Venture Full timeAbout Triveni BioWe are a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders.Our lead antibody program targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and...
-
IT Director for Patient Services
4 weeks ago
Waltham, Massachusetts, United States Madrigal Pharmaceuticals Corporation Full timeJob OverviewMadrigal Pharmaceuticals Corporation seeks a seasoned IT professional to serve as the Senior Director of IT for Patient Services. This strategic leadership role will oversee the implementation and enhancement of IT systems supporting Patient Services functions, including Patient Support platforms, CRM and communication tools for the Access &...
-
Automation Quality Assurance Specialist
4 weeks ago
Waltham, Massachusetts, United States Entegee Full timeSpecializes in custom automation projects, Entegee is a major player in the world of controls and robotic solutions around the globe. As an Automation Quality Assurance Specialist, you will be responsible for ensuring the highest quality of our custom automation projects. We are seeking a highly skilled and experienced Mechanical Inspector to join our team....
-
Quality Assurance Associate III
1 month ago
Waltham, Massachusetts, United States PSG Global Solutions Careers Full timeJob DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Quality Assurance Associate III to join our team. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our global operations.Responsibilities:Support quality oversight across GPV GBUs on PV...
-
Lead Assurance Analyst
1 month ago
Waltham, Massachusetts, United States National Grid USA Full timeAbout UsNational Grid USA is a leading energy company committed to a cleaner, greener energy future. Our team of dedicated professionals is passionate about making a real difference in the communities we serve.Job PurposeThe Lead Assurance Analyst - Gas will play a critical role in supporting the NE Assurance Team, SHA Organization, and the NE Businesses in...
-
Clinical Development Director
4 weeks ago
Waltham, Massachusetts, United States Stratacuity Full timeJob Title: Clinical Development DirectorJob Overview: Stratacuity is seeking a Clinical Development Professional to strategize, plan, and manage clinical activities for cancer immunotherapy development in a dynamic, team-oriented environment.Key Responsibilities:Design early-phase clinical trials for novel cancer treatments and write trial documents.Assist...
-
Senior Electrical Design Engineer
4 weeks ago
Waltham, Massachusetts, United States VBB Full timeElectrical Systems EngineerAt VBB, we are seeking a highly skilled Electrical Systems Engineer to join our hardware development team. This role is ideal for a self-motivated individual who can contribute to the design and development of electrical systems in medical devices.Key Responsibilities:• Plan, analyze, and implement electrical system designs to...
-
Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeRegulatory Affairs DirectorDyne Therapeutics is seeking a highly skilled Regulatory Affairs Director to lead the planning, management, and execution of regulatory activities for our product candidates in Europe, UK, and Switzerland.This role requires a strong understanding of EU regulatory requirements and the ability to develop and implement effective...
-
Senior Mechanical Design Engineer
4 weeks ago
Waltham, Massachusetts, United States Boston Engineering Corporation Full timeWe are seeking a skilled Senior Mechanical Engineer to join our team at Boston Engineering Corporation. As a key member of our mechanical engineering department, you will be responsible for developing mechanical designs of electro-mechanical products for low, mid, and high-volume production.Key Responsibilities:Develop mechanical designs of...
-
Associate Director IT Validation Lead
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director IT Validation LeadDyne Therapeutics Inc is seeking an experienced Associate Director IT Validation Lead to lead the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development,...
-
Primary Care Medical Director Opportunity
4 weeks ago
Waltham, Massachusetts, United States Mass General Brigham Incorporated Full timeMedical Director OpportunityNewtown-Wellesley Medical Group, a member of Mass General Brigham Community Physicians, is seeking a Medical Director to oversee our outpatient primary care practice located in Waltham, MA.The Role:As a key member of the clinical team, the Medical Director will report to the Director of Primary Care and provide the full scope of...
-
Senior Mechanical Design Engineer
4 weeks ago
Waltham, Massachusetts, United States Boston Engineering Corporation Full timeBoston Engineering Corporation is seeking a skilled Senior Mechanical Engineer to join our team. As a key member of our mechanical engineering department, you will be responsible for developing mechanical designs of electro-mechanical products for low, mid, and high-volume production.You will work in small multi-disciplinary teams on fast-paced projects,...