Phillips-Medisize

Risk Engineer (m/f/d) - Medical Device Development

Phillips-Medisize

Nov 1st, 2022
Phillips-Medisize, a Molex company, is a leading global outsource provider of design development and manufacturing services to the medical (medical device, diagnostics, and drug delivery products) and commercial (automotive, consumer, and defense) markets.

Our vision is to help transform the diagnosis and delivery of healthcare, and our mission is to create innovative medical device solutions that improve people’s lives.

85% of the company's total revenue comes from drug delivery, medical device, primary pharmaceutical packaging and diagnostic products. Phillips-Medisize partners with customers, providing design and development services that accelerate speed to market of innovation products. The company then works with its customers to deploy advanced automated assembly and quality control technologies which reduce manufacturing cost while improving quality.

The company's core advantage is the knowledge of its people to integrate design, molding, and automation to drive low cost and high quality manufacturing solutions.

Phillips-Medisize facilities are FDA registered for clean-room molding, medical device assembly, drug handling and packaging, sterilization management, and final device packaging under ISO 9001, ISO 14001, ISO 13485, FDA 21CFR 820, FDA 21CFR 210/211. Phillips-Medisize is an Affirmative Action/Equal Opportunity/Disability/Protected Veteran employer.
Hudson Wisconsin, United States
http://www.phillipsmedisize.com

JOB DETAILS

Location

Struer, Nordjylland

Company

Phillips-Medisize

Career Field

Research & Development/Sciences

Job Number

95207

Description

Phillips-Medisize, a Koch Company, is building solutions in partnerships with global biopharmaceutical companies to service the expanding need for self-administrated drug delivery devices suitable for especially liquid injectable drugs. To support this growing market with faster timelines to market combined with reduced development risks, several different medical device product platforms are currently in development to provide customers with a head start for launching new drugs.

Do you want to design safe and reliable medical devices, bringing our clients’ life-changing solutions into the hands of patients and helping patients to get better treatment?

Then join us and work together with your highly skilled colleagues to bring new products to market in a fast-growing and successful global company!

We are currently hiring a

Risk Engineer (m/f/d) – Medical Device Development

fulltime, in Struer or Virum, DK (hybrid working model)

What You Will Do in Your Role

  • Conducting Risk management in compliance with EN/ISO14971:2019, MDR, and Phillips-Medisize myQMS.
  • Planning, leading, and reporting Risk Management activities
  • Thorough documentation using the FMEA Med8 tool and templates.
  • Communication with internal and external stakeholders (clients)
  • Facilitating close collaboration with the project team members within risk-related areas
  • Getting a deep cross-functional technical understanding of the product
  • Contribute to continuous improvement and lessons learned.

The Experience You Will Bring

  • Master’s or bachelor’s Engineering degree or similar
  • Experience from working with risk management in a highly regulated industry
  • Experience and skills in writing, reviewing, and maintaining documentation
  • Strong teamwork capabilities and ability to take lead on workstreams
  • Great communication skills
  • Self-motivated having a persistent drive to plan and execute
  • Full professional proficiency in English

What Will Put You Ahead

  • Experience in the Medical Device Industry
  • Familiar with Medical Device Development and Design Control
  • Knowledge and understanding of ISO14971 and MDR
  • Experience with IEC 62304
  • Experience working with R&D cross-functional teams and clients

If you are interested in this role or know someone who would be a good fit, please reach out to me ([email protected]) or apply directly through the link. We are looking forward to your application!

#LI-SR7

If you require alternative methods of application or screening, you must approach Phillips-Medisize directly to request this, as we're not responsible for the employer's application process.

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