Hologic, Inc.

Design Assurance Engineer 1 CR (Temporary 12 months)

Hologic, Inc.  •  Alajuela, CR (Onsite)  •  1 day ago
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Job Description

Design Assurance is the disciplined engineering process of assuring the requirements, qualification process and results are done in the proper way for the desired goal. Provide design assurance support for on market medical devices. This role will be responsible to facilitate the application of design controls while supporting manufacturing and design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

  • Education / Educación:

    • Bachelor’s degree in life sciences, engineering, or related discipline.
  • Experience /Experiencia:
    • Previous experience is not required.
  • Specialized Knowledge (Desirable) / Conocimiento especializado (preferable):
    • Familiarity with FDA Quality System Regulations, especially Design Control requirements
    • ISO 13485
    • Medical Device Directive
    • EU Medical Device Regulation.
  • Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
    • Spanish/English
  • Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
    • Microsoft Office

Duties are listed in order of greatest importance:

  • Support Health Risk Assessments when needed for evaluation of on-market products, demonstrating efficient and effective analysis of situations, including problem definition and impact.
  • Support to internal and external audits while preparation and conduction, support to NCEs, CAPAs, SSEs, QPLs and other quality figures.
  • Support business projects such as quality management continuous improvements, internalizations, supplier changes, and value improvement projects, all while assuring quality, compliance, and safety.
  • Implementation and maintenance of Risk Management through product life cycle.
  • Participate in sustaining product projects with the support of the lead/manager, assuring the project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
  • Assess change requests of products for impact to design, and determine supporting information required for implementation of changes.
  • Support to Post Market Surveillance department regarding complaint investigation, CERs/CEPs, and other PMQA activities.

The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned above as reasonably required by business needs.

Hologic, Inc.

About Hologic, Inc.

We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.

None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities.

What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability 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 always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.

We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.

To view our community guidelines, visit: www.hologic.com/social-media

Industry
Manufacturing & Production
Company Size
5,001-10,000 employees
Headquarters
Marlborough, MA
Year Founded
1985
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