Manufacturing Engineer

You are a team player with an innovative mindset,  motivated to develop the processes needed for timely delivery of high quality leading-edge device therapy for patients with acute decompensated heart failure.

Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

What you’ll do

  • Work as part of the Technical Operations team on new product development projects, supporting process development and optimization, scale-up and technology transfer.
  • Research and deliver complex processes and technologies to accelerate time-to-market for the next generation of WhiteSwell devices.
  • Develop manufacturing processes while adhering to Design for Manufacture (DFM) and Design for Assembly (DFA) principles. Support design transfer to manufacturing activities.
  • Support production builds & yield improvement activities, including problem solving, root cause analysis & solution development.
  • Develop fixtures & equipment through all phases of design, documentation, implementation, spares & maintenance.
  • Evaluate, with the team, the process, design, and supply chain risks and develop strategies to highlight, monitor, manage and mitigate these risks.
  • Prepare reports, documents, procedures, specifications, and technical documents in accordance with Quality System requirements to ensure the success of the project.

What you bring

  • A Bachelor’s degree in biomedical, mechanical, polymer, manufacturing, materials or industrial engineering. A Masters or PhD in a related field is highly desirable.
  • 2+ years of experience in a technical role at a MedTech company with regulated products and processes. Experience of good manufacturing practice (GMP) in a cleanroom is advantageous.
  • Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles and medical device processing technologies.
  • Experience in the development and production of medical devices that require complex processes and assembly techniques and a proven ability to deliver results in this setting.
  • Excellent oral and written English language and communication skills. Can express him/herself spontaneously,  fluently and precisely, differentiating finer shades of meaning even in complex situations.
  • Working knowledge of SolidWorks CAD design is an advantage.
  • A proactive approach that enables delivery of the work required to advance the project with a minimal amount of direction.
  • Dedication to hold yourself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions, and failures.

What next

  • Apply for this position.   Upload your CV and the reasons why you’re a great fit for this job.
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Senior R&D Engineer

Curious by nature, you’re energized by challenges.  You’re a roll-up-the-sleeves leader eager to make an impact through creative problem-solving, commitment and teamwork.   

Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

What you’ll do

  • Work as part of the engineering team on complex catheter technologies to accelerate the next generation of WhiteSwell devices to market.
  • Promote an innovation mind set, identify improvement opportunities, research and suggest solutions, and submit patent disclosures.
  • Identify, evaluate, and manage relationships with key technology and component suppliers, including establishing tolerances and defining acceptance criteria related to materials, manufacturing processes, and design.
  • Map out project plans and coordinate efforts across various stages of product development, from concept to rapid prototyping to detailed design and design for manufacture.
  • Develop clinically relevant in-vitro and ex-vivo test protocols to profile device performance across a range of clinical scenarios.
  • Work closely with strategic marketing, clinical, and commercial functions as well as scientific advisors to define patient and user needs and to specify design input requirements.
  • Creatively problem solve as technical challenges arise, providing clear direction to team and while adhering to regulatory and quality requirements.

What you bring

  • A BSc in biomedical, mechanical, polymer, materials or industrial engineering. A Masters or PhD in a related field is highly desirable, or an equivalent combination of education and technical experience.
  • 5+ years of engineering experience working for a MedTech company whose products and processes are FDA regulated
  • Experience in the development and production of medical devices requiring complex processes and assembly techniques, with a proven ability to deliver results.
  • High level of self-motivation and accountability to meet commitments, proactive attitude, and sense of ownership and personal responsibility for decisions, actions and results.
  • Works well with teams, bringing a positive attitude and contributing to a supportive, respectful, goal-oriented culture. High integrity, providing an example to fellow employees.
  • Excellent report writing and presentation skills.

What next

  • Apply for this position.   Upload your CV and the reasons why you’re a great fit for this job.
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Director of R&D

A motivational leader, you will direct a team of engineers to deliver a coordinated set of programs for advanced catheter-based technologies that support timely and successful clinical evaluation and commercialization worldwide.  An excellent communicator, you will work cross-functionally and with clinical advisors to ensure business success, all while promoting a passion for innovation.   

Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

What you’ll do

  • Support and advise the VP of R&D, directing and resourcing the R&D team to deliver advanced catheter-based programs on time and on budget to ensure business success.
  • Develop and promote a culture of technical innovation, engineering from first principles, and a philosophy of being knowledge leaders in the field.  
  • Direct the innovation and knowledge capabilities of the company, creating technological value for the business. 
  • Work closely with strategic marketing, clinical, and commercial functions to define patient and user needs, to support execution of clinical and commercial programs, and to develop relationships with KOL’s. 
  • Promote a quality culture across R&D team, grounded in compliance and delivering products to specification on time and in budget.  
  • Proactively manage project technical risks and implement risk mitigation measures. 
  • Communicate effectively, supporting cross-functional business processes such as strategic planning, complaint investigation, review of invention disclosures, review of business critical documents, and problem solving.
  • Work with the VP of R&D and finance functions to ensure efficient deployment of capital on R&D programs.

What you bring

  • A BSc in biomedical, electrical, mechanical, materials or industrial engineering.  A Masters or PhD in a related field is highly desirable. 
  • 10+ years’ experience in R&D management in MedTech, with a track record of bringing new products through development to commercialization.   
  • Hands-on experience successfully leading advanced catheter development programs from concept to commercialization.  
  • Demonstrated leadership experience building and managing cross-functional, geographically dispersed teams on complex projects, delivering outstanding results.  
  • Excellent written, interpersonal communication and presentation skills.   
  • High level of self-motivation, proactive attitude, and sense of ownership and personal responsibility
  • Lead by example to build a positive, supportive, respectful culture that motivates and enables the team to accomplish strategic objectives, taking ownership for decisions and meeting commitments.

What next

  • Apply for this position.   Upload your CV and the reasons why you’re a great fit for this job.
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Senior Regulatory Specialist

You are motivated by delivering high quality, innovative technology that consistently meets the needs of customers, impacting clinical outcomes.  You are an experienced regulatory professional that enjoys collaborating with cross-functional teams, including R&D, Quality, Operations, Clinical and Marketing, to meet strategic company goals.

Join WhiteSwell, a dynamic, rapidly growing organisation, as we develop a breakthrough therapy to treat acute decompensated heart failure patients world-wide.

What you’ll do

  • Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
  • Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
  • Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
  • Develop and manage product design and technical documentation in compliance with the relevant regulations and standards, ensuring that data is controlled and is appropriately protected from corruption, misuse or damage.
  • Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
  • Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.

What you bring

  • A Bachelor’s or Master’s degree in a scientific or engineering discipline.
  • At least 7 years’ experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k) and PMA submissions.
  • Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
  • Collaborative team player with solid knowledge of the medical device design and development process.
  • Excellent written, interpersonal communication and presentation skills.
  • High level of organization with the ability to manage multiple projects.
  • Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents.
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Research & Development Engineer

You are motivated by innovation that impacts lives. You excel when dealing with complex challenges, able to dive into the details while keeping an eye on the overarching objectives. Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

What you’ll do

  • Work as part of the engineering team on new product development projects, specifically component, process, and supplier development.
  • Generate device concepts within the project team to address product performance criteria, and develop novel fixtures and test apparatus to evaluate concepts.
  • Develop ex-vivo test models and methodologies for product performance evaluations. Build and test prototypes, analysing test data to identify optimal solutions to technical challenges.
  • Manage the R&D laboratory (safety, scheduling, stock, equipment calibration) to ensure availability and function for all R&D testing needs.
  • Research state of the art technologies to identify technical capabilities that can advance and accelerate the company’s R&D projects and enhance product manufacturability.
  • Implement DFM and DFA techniques into the design and development process.
  • Evaluate, with the team, the design and supply chain risks in the project and develop strategies to highlight, monitor, manage and mitigate these risks.
  • Prepare reports, documents, procedures, specifications, and technical documents in accordance with Quality System requirements to ensure the success of the project.

What you bring

  • A BSc or MSc in biomedical, mechanical, polymer, or materials engineering. A Masters or PhD in a related field is highly desirable.
  • 1-3 years of experience in a technical role at a MedTech company or an industry with regulated products and processes.
  • Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles and medical device processing technologies.
  • Excellent oral and written English language and communication skills. Can express him/herself spontaneously, fluently and precisely, differentiating finer shades of meaning even in complex situations.
  • Proficient in SolidWorks CAD design.
  • A proactive approach that enables delivery of the work required to advance the project with a minimal amount of direction.
  • Dedication to hold yourself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions, and failures.
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Our team has locations in Ireland, Israel, and the U.S.

WhiteSwell – Ireland

Parkmore Business Park West
Parkmore, Galway, H91 PTT8
Ireland

+353 91 394 110

info@whiteswell.com

WhiteSwell – Israel

Hutsot Shefayim Commercial Center
Shefayim 6099000
Israel

info@whiteswell.com

WhiteSwell – USA

1900 S. Norfolk St., Suite 350
San Mateo, CA 94403
USA

info@whiteswell.com

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