Additional Location(s): N/A
About the role:The Design Assurance Engineer directly supports medical devices through operations, product development and sustaining functions. Develop, establish, and maintain quality-engineering methodologies, system, and practice which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.
Work Mode:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Relocation Assistance:Relocation assistance is not available for this position at this time.
Visa Sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:- Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
- Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
- Champion compliance to company policies, work instructions and SOPs.
- Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
- Support internal and external regulatory audits as required.
- Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management
Required Qualifications- Minimum of a Bachelors degree in Biomedical Engineering, Mechanical Engineering or related degree.
- Minimum of 3 years of medical device engineering experience.
- Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
- Travel approximately 10-20%.
Preferred Qualifications:- Strong communication (oral and written) and presentation skills.
- Ability to collaborate and work on Global team
- Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies (Six Sigma / CQE certification preferred).
Requisition ID: 636304Minimum Salary: $ 82100 Maximum Salary: $ 156000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
