Heraeus Medical Components facility in Costa Rica

Together we improve lives. At Heraeus Medevio, we leverage our breadth of expertise in material science, leading-edge technologies, and supply chain excellence to build sustainable and successful partnerships with medical device OEMs. As a result, the quality of the work we do is felt and trusted by our partners and the patients who rely on them for life-saving and life-changing medical devices.

We are relentless in our pursuit of doing things better because we know that today’s best is simply tomorrow’s building block for what’s next. As a global company headquartered in the medical device hub of Minnesota, with 10 locations in the Americas, Europe, and Asia, two Collaboration Hubs dedicated to R&D, and 2,000 employees worldwide, we are committed to the growth of our teams and our organization. To help drive this growth, our company is backed by a Global Fortune 500 holding corporation that has been around for more than 200 years, with a history of providing open spaces for open minds.

Our vision is to improve 100 million lives each year. To accomplish our vision, we have built a culture of curiosity that thrives on challenge, continuous learning, and the opportunity for our people to advance and develop. Good ideas are celebrated here, so join us as we act boldly, think openly, work thoughtfully, and with our partners, improve patient lives worldwide.

Open Positions Spotlight

Global Contract Administrator

Location

Fridley, MN, USA

Education

Bachelor’s degree

Experience

Recommend: 5+ years of contract management experience in manufacturing or related environment.

Experience working within a global organization a plus.

Knowledge and Skills

Demonstrated work experience with legal documents and scenarios requiring tight coordination across multiple groups and departments.

Strong analytical, investigative, and problem-solving skills.

Strong organizational skills, ability to multi-task, and manage multiple projects.

Attention to detail, and professional with a collaborative nature.

Ability to effectively evaluate and communicate with various stakeholders.

Ability to build positive working relationships and influence others.

Ability to maintain confidentiality of legal matters.

Project Manager

Location

St. Paul, MN, USA

Education

Bachelor's Degree Required

Project Management Professional (PMP) certification preferred

Experience

Minimum of 5 years of relevant work experience required

Knowledge and Skills

Knowledge and application of project management tools, processes, and best practices, with experience using multiple project management methodologies

Experience conducting risk management activities to identify, assess, control, and learn from project risks

Understanding of finance fundamentals and ability to utilize data to make project decisions and evaluate performance

Ability to conduct project governance activities for multiple projects and report trends of systemic challenges

Demonstrated understanding of organizational relationships, dependencies, and escalation paths and appropriate communication

Established ability to positively motivate and influence others to build a strong team

Strong verbal and written communication skills

Experience with conflict resolution

Strong critical thinking and problem-solving skills

Proven ability to manage change

Senior Engineer - Product Engineering

Location

Fridley, MN, USA

Education

Bachelor’s degree in Engineering or related technical field required, master’s degree in Engineering or related technical field helpful

Experience

Minimum of 8 years of relevant work experience required

Knowledge and Skills

Well established knowledge of multiple engineering functional areas (i.e. product development, test, modeling, process, etc.)

Independently applies knowledge of the methodology for process/design selection

Able to communicate complex technical concepts to broad audiences

Consistently demonstrates creativity in applying engineering principles to solve complex problems

Able to make data driven decisions utilizing statistical tools such as DOE, tolerance stack-up analysis, or Minitab

Strong independent problem-solving skills and actively works to coach others in this area

Proficient with new technology development

Capable of creating a plan to solve complex technical problems and lead others to resolution

Actively, informally or formally coaches and mentors less experienced engineers

Senior Maintenance Technician

Location

St. Paul, MN, USA

Education

Associate’s degree

Experience

Minimum of 8 years of relevant work experience required

Knowledge and Skills

Demonstrated understanding of manufacturing processes and principles, design intent, customer end use, and impact of critical dimensions on product performance.

Basic inspection tools, machining skills, Statistical Process Controls, and intermediate computer aptitude desired; must have solid mechanical ability.

AutoCad knowledge plus.

May act as a lead on some projects and give work direction to other technicians.

Ability to lift up to 50 lbs, plus bending, stooping and standing throughout the day.

Good peripheral vision, hand/eye coordination.

Senior Product Manager - Electrophysiology

Location

Fridley, MN, USA

Education

Bachelor’s degree required; master’s degree helpful

Project Management Professional (PMP) certification preferred

Experience

Minimum of 8 years of relevant work experience required including previous experience in the medical device industry.

Knowledge and Skills

Expert level knowledge and application of project management tools, processes, and best practices using multiple project management methodologies

An established history of building strong teams and cross-functional relationships

Excellent verbal and written communication skills

Demonstrated ability to interact with a diverse group of project stakeholders including customers, executives, peers, managers, and subject matter experts

Proven competence in completing projects according to established scope, budget, and timelines

Extensive experience guiding teams in risk assessment and mitigation activities

Strong knowledge and application of finance fundamentals as related to projects

Expert level background in conflict resolution

Excellent analytical and problem-solving skills

Must be willing and able to travel up to 25%, mainly between Minnesota and Costa Rica

Supplier Quality Engineer II

Location

St. Paul, MN, USA

Education

BS degree in engineering or technical related field

Experience

1 or more years of experience as a Quality Engineer or Supplier Quality Engineer

1 or more years of experience with supplier/internal auditing

Knowledge and Skills

ISO 13485 and/or 9001 standards

Ability to do local and domestic travel up to 30% of the time

Desired:

ASQ certified Quality Engineer

Knowledge with MS Office, Visio and Statistical Software

Medical Products experience

Process Development Engineer II

Location

Cartago, Costa Rica

Education

Bachelor’s Degree in Engineering (Mechanical, Biomedical) or related technical field required

Experience

A minimum of 2 years engineering experience within medical device development or manufacturing environment

Knowledge and Skills

Familiarity with cGMP/GLP/GDP guidelines, ISO 13485, 21 CFR part 820, etc.

Demonstrated strong technical writing skills to support and drive process and qualification documentation required

Experience with guidewires or catheter manufacturing processes preferred (Wire grinding, profiler, inspection equipment, and CNC machining are desired)

Demonstrated experience of process development, capability, optimization, and validation. Application of statistical and analytical methods such as DOE highly desired.

Experience with troubleshooting, maintenance and repair of manufacturing equipment.

CAD/CAM experience or training; SolidWorks highly desired or equivalent job experience.

Must possess proficient written and oral communication skills and ability to utilize MS Office suite tools

Previous experience in document control and SAP preferred

Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel)

Proficiency in reading, writing and speaking English. Must be able to clearly articulate and listen attentively to questions, concerns and feedback from coworkers and customers. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations

Highly motivated hands-on engineer with the ability to work independently and as part of a cross-functional team

Senior Engineer - Automation

Location

Cartago, Costa Rica

Education

BS in Engineering required

Experience

A minimum of 8 years of relevant experience in equipment development; Medical device industry experience required

Experience with CAD for machine design, SolidWorks preferred

Knowledge and Skills

Must demonstrate strong collaborative communication skills

Must possess a strong general understanding of mechanical, electro-mechanical, and automated systems

Must develop and follow a disciplined and detailed approach to project management and design process

Must be able to manage multiple parallel projects with varying scopes and deadlines from concept to production qualification using established HMC processes

Must be able to draw on prior knowledge and experience and adapt to initiate effective solutions to problems at hand

Must demonstrate a high level of initiative and creativity. Must be able to perform independently

Must be comfortable working in a fast-paced environment. Must be adaptive to change and willing to support a variety of work assignments to fulfill internal and external customer expectations

Excellent and clear verbal and written communication skills in English

Must be willing and able to travel as needed (up to 15%)

Ability to perform occasional lifting (up to 35 pounds), bending, stooping, sitting, standing

R&D Project Manager Medical Devices

Location

Dresden, DE

Education

Technical engineering degree (preferred Biomedical, Elelctrical or Mechanical Engineering)

Experience

A minimum of 5 years professional experience in the medical device industry.

Knowledge and Skills

You have a proven track record in project management/ stakeholder management including commercial project accountability.

You are an expert in design and development activities for medical devices.

Excellent communication skills. German language skills would be beneficial.

Quality System Specialist

Location

Dresden, DE

Education

You have successfully completed vocational training or a successfully completed a degree (Bachelor).

Experience

Ideally, you have experience in quality, CAPA management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally at least 3 years) and enjoy specialized training and further education.

Knowledge and Skills

Basic knowledge of the relevant standards (e.g. ISO 13485/ 21CFR820 / ISO 14971) complete your profile.

You have a good command of written and spoken English, are solution-oriented, a team player and enjoy working in an international environment where you can demonstrate your excellent communication skills.

A qualification as an internal auditor as well as knowledge of root cause analysis / problem solving methods (e.g. 5Why, Ishikawa) are desirable.

Quality Engineer Pilot Production

Location

Dresden, DE

Education

You have successfully completed a degree in the technical field (min. Bachelor) and acquired additional qualifications in the areas of QM systems (e.g. ISO 9001/ ISO13485/ 21CFR820).

Experience

Ideally, you have experience in quality, CAPA management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally at least 3 years) and enjoy specialized training and further education.

Knowledge and Skills

You bring several years of experience in process validation/qualification and software validation in controlled industries (e. g. medical devices, automotive, aerospace, pharmaceutical industry) and ideally basic knowledge of development/design control of medical devices and knowledge of regulatory requirements.

You have a good command of written and spoken communication in English, are a team player and solution-oriented?

Continuous willingness to learn as well as enjoy specialist training and further education.

Quality Systems Manager

Location

Dresden, DE

Education & Experience

You have successfully completed your studies and have several years of experience in quality management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally 5+ years).

Knowledge and Skills

Throughout your professional career you were able to acquire comprehensive knowledge of recognized QM systems (e.g. ISO13485/ FDA/ ISO14971) and apply them confidently.

Ideally, you have basic knowledge of regulatory requirements for medical devices (e.g. MDR, MDSAP) and are a proficient user of quality tools.

Daily communication and documentation in English is no challenge for you.

Your working style is independent, goal/solution oriented and structured, you are a team player and enjoy communication in diverse team structures.

Continuous learning is a matter of course for you and you enjoy technical trainings and further education.