Head, Laboratory Solutions Design Quality and Product Sustainability
Siemens Healthcare Diagnostics Inc.

Job Info

---

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Apply now for the position of Head, Laboratory Solutions Design and Environmental Quality , and you will provide global strategic and hands-on leadership to the Design Quality and PREP Departments for Siemens Healthcare Diagnostics, Inc.

A senior leader providing strong quality and environmental leadership, knowledge and experience overseeing a Team of engaged professionals responsible for Design Control excellence and compliance related to IVD instrument, software product development, and sustainability requirements from both National Authorities and the Corporation. This leader and their Team partners with Design and Change Teams to ensure they meet the intent of regulations, standards, and internal procedures to achieve both business goals and compliance. The role has strategic impact on the overall success of the Laboratory Solutions business.

In managing Design Quality, they will lead cultural, process and procedural changes within Quality and R&D to align with cGMP practices. They will have demonstrated experience in executing a nd leading a collaborative approach in execution of best practices of Design Control regulations, designing and implementing Quality System Procedures and Work Instructions, and understand impacts of Design Controls as inputs to Manufacturing and Manufacturing Transfer costs for ongoing production. This leader must develop strategic quality programs and Critical-To-Quality initiatives to oversee and foster: Design changes, New Products, product enhancements, material changes, software creation and maintenance and represent Design Controls expert-level leadership and guidance for a dedicated team.

As the head of Product Sustainability, they will directly engage with SHS Corporate offices on Product Sustainability directly influencing Healthineers approach in meeting Corporate-wide goals. They will represent corporate direction back to DX overall. They will be responsible for maintaining awareness of changes in global sustainability laws, regulations and standards affecting PREP-related topics (e.g., REACH, RoHS, EU CLP, India RoHS, Extended Producer Responsibility, Eco Design etc.) and analyses impacts for IVD global market access, implementing requirements via local procedures and training where relevant. Plans and directs requirements establishment for research & development (R&D) to implement PEP-related impacts within LS. Ensures all PEP projects, initiatives, and processes are in conformance with organization's established policies and objectives.

Essential Job Functions

Responsibilities include but are not limited to the following:

• Lead and direct a team of Engineers, Scientists and EHS professionals who help educate and provide direction to R&D in the application of design controls in state-of-the-art IVD product development.

• Manage/supervise personnel with respect to project resources.

• Coordinates efforts to understand and inform implementation of PEP regulations and standards.

• Oversees project deadlines and budget while considering the financial goals of the company and the needs of internal/external customers.

• Provides timely updates to DX LS QT Management Team to ensure the business can adequately plan for implementation of any PEP-related standards and/or new legal requirements.

• Ensures upkeep of documentation and reporting requirements from PREP related project activities

• Issues monthly regulatory updates to the DX LS-QT Management Team

Critical Competencies

• Attention to detail and quality in all initiatives.

• Trained/experience in Root Cause analysis and Design of Experiments

• Demonstrated ability to build cross-functional relationships while meeting team goals.

• Demonstrated ability resolve to resolve complex problems across functions.

• Demonstrated expert-level knowledge of Design Controls, Design for Six-Sigma, Critical-to-Quality strategies, Risk Management, Cybersecurity, Safety Assurance Cases, and Human Factors, etc.

• Directs complex activities and provides recommendations regarding technical plans and reports.

• Strategic project management skills - with a strong emphasis on regulatory projects and budget experience

• Experience working and collaborating with representatives from both internal and external organizations.

• Creativity in organizational approaches to Design and PREP solutions/issues

• The ability and experience to relate well and establish/maintain credibility with senior leadership.

• Demonstrates excellent performance in previous project / standards work and documented high potential for development and growth in this position.

Education/Qualifications

• BS degree in Engineering or relevant discipline with a master's or PhD with 15+ years of experience in a medical device/IVD environment

• 10+ yrs. Leadership experience managing teams in Design/Project Management and/or Quality Engineers in FDA/ISO13485 Design Control Environment

• Multiple experiences in Product Development including leadership of activities and members in delivering Design effort documentation.

• Direct Experience in full product development cycle (lifecycle management)

• Demonstrated ability to make risk-based decisions with products' impact considering Users, Patients, Servicing and Manufacturing aspects of the product.

• Previous experience working with the European Union Regulations/Directives

• Previous experience working within regulatory associations such as MedTech a plus.

To find out more about the specific business, have a look at https://usa.healthcare.siemens.com/about

The pay range for this position is $250k - $285k U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. The annual incentive target is (25%) of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from diverse backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site .

"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities.

To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

Reasonable Accommodations
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accomodation for disablity form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here .

This job has expired.