דרושים Industrial/ Manufacturing Engineer ב-Boston Scientific ב-הולנד

In this role, you will drive the growth of our innovative Interventional Oncology portfolio (including Cryoablation, SIRT – Selective Internal Radiation Therapy, and Embolization) across Western Poland.

Your main mission is to build and strengthen relationships with Key Opinion Leaders (KOLs), hospital administration & medical societies to increase the number of patients treated and expand market share for our product franchises.

You will act as the link between professional associations, clinics, and internal teams such as sales, marketing, and clinical specialists. This means leading market penetration through targeted networking, clinical advocacy, and strategic sales activities.

Key Responsibilities

• Stay up to date on industry, competitive, healthcare, and economic trends, and assess their impact on short- and long-term business plans.
• Identify new business opportunities by developing and leveraging partnerships with academic and research institutions and KOLs.
• Design and implement sales strategies to grow the number of patients treated with our portfolio products.
• Support physicians and hospital staff through education, workshops, and training — including patient identification, referral pathways, and treatment follow-up and on-going patient monitoring procedures.
• Actively participate in conferences, courses, and industry forums hosted by the company or external partners.
• Work closely with sales teams to build and maintain relationships with decision-makers in key accounts.
• Transfer projects to local sales teams after successful implementation, focusing on expanding into new accounts.
• Provide clinical support during IO procedures (sterile field), including device preparation, technical support, and system troubleshooting.
• Device Management: monitor inventory levels, initiate logistics, i.e. shipments and movement tracking of products. Monitor the levels and expiration dates of products in the field. Coordinate communication between internal and external customers to facilitate material management.

Your Profile

• Minimum of 5 years’ professional experience in sales or business development related positions within the medical or pharmaceutical industry.
• Strong background in selling complex, consultative solutions (preferably in medtech or pharma).
• Experience in organizing workshops or training sessions is a plus.
• Solution-oriented mindset, creativity, and the ability to work independently on diverse business challenges.
• Excellent interpersonal skills, credibility, and persuasiveness.
• Proven experience in building strategies for product launches.
• Goal-oriented, with a strong track record of achieving results in team environments.
• Strong communication and presentation skills.
• Category B driving license.
• Very good English skills, both written and spoken.
• Willingness to travel extensively (domestic and international).
• Active participation in congresses, symposia, and workshops.
• Confident, proactive, and motivated personality with analytical and entrepreneurial thinking.
• Open, positive attitude with a passion for sales and market development.

What We Offer

• A competitive compensation and benefits package
• Working in an international environment
• Possibility to make an impact
• Fast Growing and innovative environment
• Language courses
• Free and confidential counselling support/program (Psychological, Financial, Legal)
• Parental leave policy
• Medical Care (Premium Package)
• Life insurance
• Lunch Card
• Employee Stock Purchase Plan
• Employee Savings Plan

About the role as Senior EH&S Engineer:

To develop, implement, and ensure continuous improvement on Environment, Health and Safety (EH&S) within our European Center of Operations in Kerkrade.The primary purpose of this function is: maintaining compliance with the requirements of all applicable

Acts as Expert Employee (Preventiemedewerker).

Your responsibilities will include:Develops, maintains, and reviews the EH&S program to ensure compliance with current and future legal, regulatory, and corporate requirements.

Proactively identifies and promptly addresses EH&S issues which may affect operations or may provide strategic advantage to the business and provides input for management review meetings.
Establishes and tracks metrics for assessing EH&S effectiveness in the organization, includingEnvironmental, Health & Safety accidents and incidents, management walks, energy, waste, emissionsand develop/support plans toimprove performance .Maintains an appropriate EH&S culture through cross-functional cooperation, communications, promotions, and training including employee training on EH&S procedures, industrial hygiene activities, safety surveys, review and revision of local procedures.Responsible for the ongoing development and implementation of the Energy, Environmental and Health & Safety Management System. (ISO 14001, ISO 50001 & 45001).

Responsible for the ongoing development and implementation Energy Management.

Responsible for appropriate procedures, approvals, coordination, and control ofdangerous goods andMaintains all EH&S regulatory reporting requirementsand communicates with governmental agencies.
and all other emergency situations.
Investigates accidents, incidents and works with local management to identify necessary corrective actionsand follow up.Monitors Risk Assessment Programmes and ensures the close out of action items.
Maintains the EHS Corrective Action System and follows up to ensure the close out of items.
Helps in the identification of initiatives which promote and develop improvements in EHS performance.
Initiates, participates in and drives projects which improve on site EHS performance.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Manage the EH&S pillar of the Kerkrade site.

Leadership

• Provides formal day-to-day coordination to the team including setting performance and productivity expectations, coaching on performance and development, coordinating activities, checking on quality and work progress
• Reviews processes and maintains continuous improvement practices for team
• Implements performance evaluation tools to develop a high performance team

Interactions (and Communications)

• Requires tact and diplomacy to communicate standard information and exchange ideas in a concise and logical way; understands when to involve specific stakeholders
• Assigns short-term tasks to team members and conveys performance expectations
• Handles straightforward issues with employees and/or customers (internal or external) using sensitivity for appropriate communication.

Management Requirements

• Lead the team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Who are we looking for:A degree (preferrable HVK or MVK) in environmental, health and safety or related scientific field and a minimum of two years of related experience.
Experience with developing, implementing and maintaining of EHS management systems
Strong competence with the various tools, reporting and procedures used to accomplish the job.
Knowledge/experience with working in a manufacturing or supply chain environment preferred.
Demonstrate knowledge local health and safety, and environmental regulations is required.
Knowledge of ISO Standards (ISO 14001, ISO 50001, ISO 45001)
Knowledge of the Dutch and English language

People leader skills

To thrive in this job, you’ll need the following skills:
Excellent written and verbal communication skills.
Ability to conduct trainings/presentations to different audiences
Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats.
In-depth knowledge of EH&S regulations and regulatory requirements.
Uses strong project management skills in facilitating projects/activities.
Ability to effectively work withEH&S databases,perform data entryand analyze data.

What we offer you:

• Attractive benefits package - very competitive salary (including 8% holiday pay, 13th month and yearly bonus)
• 30 days of annual leave
• A very good pension scheme
• A stock purchase program
• Excellent training/development programmes to influence your career
• Inhouse gym facility (free of charge)
• Option to lease a (electric) bicycle
• Inspirational colleagues & culture
• Fast Growing and innovative environment
• A team-oriented company culture
• International opportunities
  

Netherlands-Kerkrade; Belgium-Diegem; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Spain-Madrid

Field Clinical Engineer– EMEA

About the Role:

The Field Clinical Engineer (FCE) supports a growing department that manages a large pivotal study program based on an innovative medical device technology platform. The FCE will be responsible for all aspects of case support and product education aimed at treating patients with hypertension.

This is a remote position with up to 75% travel required.

Your Responsibilities Will Include:

• Working under general direction, provides engineering, educational, and technical support in response to field inquiries from physicians and health care professionals involving the company’s renal denervation product.
• Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost-efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.
• Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager.
• Acts as a clinical interface between the medical community and the business.
• Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly.
• Provides engineering, education, and clinical support in response to field inquiries on an as-needed basis. Demonstrates a thorough command of the TIVUS product , related product and technical knowledge, trends, and players.
• Develops, leads, and/or facilitates trainings and other programs for healthcare professionals.
• Provides insight, guidance, and feedback to management on market feedback and components of next-generation products.
• Provides regional procedural case coverage , potentially across the EMEA region .
• Provides additional back-up support in the following areas:
• Clinical study monitoring/data collection
• Troubleshooting
• New product in-service training to physicians and healthcare professionals
• Continuously develops engineering and technical skills aligned with the company’s strategic goals.
• Assists with advanced educational seminars and preparation of educational materials.
• Assists with advanced product demonstrations to visiting physicians and healthcare professionals.
• Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends.
• Resolves and/or facilitates resolution of problems, including identifying causes to prevent re-occurrence.
• Performs related functions and responsibilities, on occasion, as assigned.

What Are We Looking For:

• A Bachelor’s degree in Biomedical Engineering, related field, or equivalent healthcare experience.
• A minimum of 5 years of clinical research experience , including coordination of multi-center trials and a solid technical background.
• Fluency in both German and English , written and verbal, to support regional collaboration, training, and communication with internal and external stakeholders.
• Ability and willingness to become certified on the Renal Denervation product .
• Comfortable with extensive travel—up to 75% domestically and within the EMEA region .
• Demonstrated ability to present, write, and teach clinical and medical information effectively.
• Hands-on experience with interventional or catheter-based procedures .
• Strong cross-functional collaboration skills—able to work with engineers, vendors, and customers across various disciplines.
• Proven capability to manage multiple assignments simultaneously while maintaining attention to compliance and detail.
• A proactive approach to identifying and escalating clinical or protocol-related concerns.

Preferred Qualifications:

• Strong communication skills and fluency in medical terminology.
• Clinical research experience specific to the medical device industry.
• Experience in multi-center cardiology trials .
• Familiarity with GCP and ICH guidelines for regulatory compliance.
• Proficiency in Microsoft Office tools and database management systems.

About the Role

The Principal Quality Engineer will ensure FDA and warehouse audit readiness. This position will be either hybrid or onsite located at the Kerkrade, NL site. The Quality team is responsible for quality and operational oversight to ensure processes are in compliance with Boston Scientific requirements, ISO 13485, EU MDR 2017/745, and 21 CFR 800 standards and regulations, as applicable to the warehouse and distribution center.

Your responsibilities include:

• Implement, maintain, and improve the Kerkrade Quality Management System.
• Responsible for working with Quality management, department personnel and other areas on process reviews and implementation of requirements to ensure site audit readiness
• Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC BestQuality Strategy.
• Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, EU MDR, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Drive continuous improvements in the distribution center
• Act as a coach/ mentor to aid development of junior staff members
• Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, VIP, QMP, StAR, Lean, 5S).
• Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of Boston Scientific
• Is viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions using the Site QA Associate Director and Quality Systems Manager as the final arbitrator on critical quality decisions.

What we are looking for:

• 5+ Years lead auditor experience
• 5+ Years relevant experience in a GMP Medical Device Manufacturing environment
• Experience in a Distribution center is a plus.
• Green Belt certified (is a plus) with process management experience
• Familiar with quality tools and problem-solving techniques
• Team player with strong work ethic and positive mentality
• Computer literate
• Good social and communication skills
• Strong analytical skills, "self-starter" and eager to improve
• English language proficiency

What we offer you:

• Attractive benefits package - very competitive salary (including 8% holiday pay, 13th month and yearly bonus)
• 30 days of annual leave
• A very good pension scheme
• A stock purchase program
• Excellent training/development programmes to influence your career
• Inhouse gym facility (free of charge)
• Option to lease a (electric) bicycle
• Inspirational colleagues & culture
• Fast Growing and innovative environment
• A team-oriented company culture
• International opportunities
  

About the role:
Functions as the Quality workstream lead for Equipment Software Qualification and Validation supporting implementation of an Automated Storage and Retrieval System and other systems for a project at the Kerkrade Distribution Center.

Fixed term: 1 year with potential extension upon project’s need

Responsibilities include:

• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS, Software Qualification documentation and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes.
• Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What are we looking for:

• 5+ years’ experience with Bachelor’s Degree or equivalent in a quality controlled environment
• Comprehensive understanding of the MDD/EU MDR, ISO standards and cGMP
• General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function.
• Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Demonstrates knowledge in teamwork, project management, problem solving and risk management techniques
• Effective team member, fully motivated to achieve and demonstrate best practices in line with the department & global objectives
• Good social and communication skills
• Strong analytical skills, eager to improve and results oriented
• Professional proficiency in English language (verbal and written)

Preferred Qualifications:

• Experience with supply chain distribution and packaging
• Medical device industry experience