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Boston Scientific

Medical devices maker for interventional specialties

Product Complaint Investigator III - Temporary 1 year, Quality

ContractUpdated
No salary listed
Senior
Bachelor's
El Coyol, Alajuela Province, San José, Costa Rica
HybridHybrid roles include work-from-home and onsite work; details are discussed during the interview.
Manufacturing Quality & TestQuality Engineering

About the job

Requirements
  • Solid functional knowledge and working business understanding within regulated environments.
  • Advanced problem-solving skills with minimal guidance.
  • Strong technical communication and analytical presentation skills.
  • Ability to influence peers, local leadership, and cross-functional teams.
  • Coaching and mentoring capability for junior investigators.
  • Demonstrated ownership of complex complaint investigations.
  • Working knowledge of industry practices and internal processes.
  • Commitment to completing 100% of assigned training within required timelines.
  • Demonstrated accountability and adherence to the Code of Conduct.
Responsibilities
  • Execute product complaint investigations across major product families, including complex analysis and technical documentation.
  • Maintain ownership of SEFs and support minimal-impact NCEP activities with guidance when required.
  • Analyze data independently and present findings in complex forums, including SER or cross-functional reviews.
  • Apply advanced technical writing skills to document investigation outcomes and supporting evidence clearly.
  • Identify and escalate out-of-spec results while proactively engaging cross-functional partners.
  • Independently coordinate meetings with functional stakeholders, including Quality, R&D, Manufacturing, and DA.
  • Contribute to new product or acquisition integration by applying existing investigation knowledge.
  • Train, mentor, and coach junior investigators and support investigation approvals.
  • Participate in and influence continuous improvement initiatives, VIP submissions, and curiosity mindset activities.
  • Support external communications and regulatory responses as needed.
  • Deliver assigned project milestones and support PMQA or divisional initiatives.
Desired Qualifications
  • Experience presenting investigation outcomes in complex forums, including SER or cross-functional reviews.
  • Experience owning SEFs and supporting NCEP activities.
  • Exposure to new product integration or acquisition-related complaint support.
  • Experience supporting regulatory responses or external communications.
  • Strong participation and influence in continuous improvement initiatives, including VIP and Kaizen.
  • Demonstrated ability to influence technical decision-making.
  • Experience mentoring and supporting approval processes for junior investigators.
  • Demonstrated engagement in Diversity & Inclusion initiatives.
  • Technical degree in Quality, Electrical Engineering, Production, Customer Service, or a related field.
  • English proficiency at 70–79%.
  • At least 5 years of experience.

About the company

Boston Scientific designs and makes medical devices used in procedures across cardiology, endoscopy, urology, and neuromodulation. Its products help doctors diagnose and treat conditions by guiding minimally invasive interventions and delivering therapies inside the body, with revenue from hospitals and clinics. The firm differentiates itself through a broad, global portfolio and heavy ongoing investment in research and development to expand capabilities and address complex health issues. Its goal is to improve patient care by providing reliable, effective medical devices and solutions that enable clinicians to perform safer, more effective procedures while growing its business.

Company Size

10,001+

Company Stage

IPO

Headquarters

Marlborough, Massachusetts

Founded

1979

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Simplify's Take

What believers are saying

  • September 11, 2026 FDA clearance for SpaceOAR Flex expands prostate cancer workflow offerings.
  • Boston Scientific restored remote cardiac monitoring and most operations by September 8, 2026.
  • Second-quarter 2026 sales grew 7.5%, showing strong demand before the cyber disruption.

What critics are saying

  • August 25, 2026 cyberattack forced Boston Scientific to miss 2026 sales and profit guidance.
  • September 25, 2026 FDA Class I recall removed Imager II Angiographic Catheters after tip defects.
  • AXIOS and Infinion CX recalls show repeated manufacturing and design-quality failures across franchises.

What makes Boston Scientific unique

  • FARAPULSE remains Boston Scientific's category-defining pulsed-field ablation franchise in 2026.
  • SpaceOAR Flex extends a differentiated prostate-radiotherapy portfolio with real-time flexible delivery.
  • Global scale across cardiology, endoscopy, urology, and neuromodulation diversifies procedure-dependent revenue.

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Benefits

  • Relocation Assistance
  • Performance Bonus

Growth & Insights and Company News

6 month growth

0%

1 year growth

12%

2 year growth

12%
Yahoo Finance
Oct 28th, 2026
Boston Scientific hit by cyber outage and cyclical slump, plans $500M savings as 2027 seen as trough

Boston Scientific said a cyber security incident hurt its third-quarter results, causing a two-week outage with eight business days of manufacturing and shipping disruption. The attack cut sales growth by about 300 basis points and earnings per share by $0.07, and lost revenue came to $150 million. The company expects 2027 to be the low point of its cycle, with recovery in 2028. Weakness in its electrophysiology and WATCHMAN franchises, and pricing pressure in China, weigh on growth. A restructuring programme should save more than $500 million over three years. It also booked an $80 million charge, mostly for product liability cases. The Penumbra acquisition is now expected to close in early 2027 because of regulatory timelines.

Yahoo Finance
Oct 28th, 2026
Boston Scientific beats Q3 revenue with $5.14B but Q4 guidance of $5.18B misses; shares fall 3%

Boston Scientific beat third-quarter revenue estimates but gave weak guidance for the next quarter. Revenue rose 1.4% year on year to $5.14 billion, against analyst expectations of $5.07 billion. Adjusted earnings per share were $0.73, in line with estimates. The medical device maker guided fourth-quarter revenue to $5.18 billion at the midpoint, below the $5.42 billion analysts expected. It also cut its full-year adjusted earnings per share guidance to $3.17 at the midpoint, a 3.9% decrease. Operating margin fell to 16.1% from 20.7% a year earlier. Shares fell 3% to $43.71 after the results. Chief executive officer Mike Mahoney called it "a challenging year," citing the cybersecurity incident, but said he remains confident in the company's long-term strategy.

PR Newswire
Oct 28th, 2026
Boston Scientific Q3 sales rise 1.5% to $5.14B as cyberattack weighs; Q4 decline forecast

Boston Scientific reported third-quarter 2026 net sales of $5.138 billion, up 1.5% from a year earlier. The company said the period was hit by a cybersecurity incident first reported on August 26, 2026. GAAP net income fell to $582 million, or $0.40 per share, from $755 million, or $0.51 per share. Adjusted earnings per share were $0.73, compared with $0.75 a year ago. Cardiovascular sales rose 1.9%, while MedSurg grew 0.6%. By region, Latin America and Canada grew 16.0%, and the US rose 0.5%. The company now expects full-year net sales growth of about 4.25% and adjusted earnings per share of $3.16 to $3.18. It expects fourth-quarter sales to fall 1% to 3%.

Nine80 Digital
Oct 20th, 2026
Boston Scientific Recalls 199 Microcatheters Distributed to South African Hospitals.

Boston Scientific Recalls 199 Microcatheters Distributed to South African Hospitals. Thomas October 20, 2026 Boston Scientific Recalls 199 Microcatheters Distributed to South African Hospitals. Boston Scientific has recalled 199 Direxion and Direxion HI-FLO Torqueable Microcatheters distributed to healthcare facilities across South Africa, following a manufacturing issue that could affect the devices' movement during medical procedures. The recall, dated 20 October 2026, affects products supplied to healthcare facilities including Diagnostic Radiological Services, Groote Schuur Hospital, Netcare facilities, Life Wilgers Hospital, Life Peglerae Hospital, Capital Radiology and other healthcare providers. According to the supplier, the manufacturing issue may make it difficult to remove the affected microcatheter from its carrier hoop or to advance and withdraw it through a guide catheter. Increased resistance during these processes may damage the device, potentially affecting its performance during a procedure. The recalled products are single-lumen, multipurpose microcatheters used by healthcare professionals to access treatment sites in the peripheral vasculature during medical procedures. The supplier has identified life-threatening embolism as the most serious potential harm associated with a dysfunctional microcatheter. The likelihood of this occurring has been assessed as remote. The National Consumer Commission (NCC) has advised healthcare professionals to immediately discontinue use of the affected products. Healthcare facilities have also been advised to remove the affected devices from their inventories and segregate them in a secure location while awaiting their return to Boston Scientific. The NCC further advised healthcare professionals to consult the supplier's recall notice to verify whether products in their possession are affected by checking the relevant product and lot numbers. The recall applies to the identified Direxion and Direxion HI-FLO Torqueable Microcatheters distributed to healthcare facilities nationally. The NCC's guidance is directed at healthcare professionals and facilities handling the affected devices, with the immediate focus on preventing further use of products covered by the recall. Boston Scientific is the biomedical and biotechnology company supplying the recalled devices. The recall follows the identification of the manufacturing issue affecting removal from the carrier hoop and advancement or withdrawal through a guide catheter.

Yahoo Finance
Oct 15th, 2026
Boston Scientific risk rises as $2.72B capex tops R&D for the first time since 2011

Boston Scientific shares have fallen 54.7% over the past year, against a 17.3% gain for the S&P 500, even as the medical device maker grew revenue 13.5% in the twelve months to June 2026. In August, a cyberattack disrupted its manufacturing and order shipments. Risk has risen because capital spending reached $2.72 billion, above the $2.15 billion spent on research. Research had led at every quarter end since at least September 2011. Most of the extra spending came in April to June, at $1.93 billion versus $245 million a year earlier. Free cash flow fell to $1.81 billion from $3.18 billion, while total debt rose to $12.6 billion from $12.0 billion. On July 29, management cut its 2026 revenue growth forecast to 6.0% from 7.8%. The next report, expected around October 28, 2026, covers the quarter the attack hit.