Siemens Sr Mgr, Engineering in East Walpole, Massachusetts
Sr Mgr, Engineering
Locations:East Walpole, Massachusetts
Job Family: Engineering
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 226742
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 25%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
Role: Sr. Manager: Marco & Draco programs
This position reports to the Sr. Director of Engineering for the Strategic Reagents Manufacturing Projects Group
The Engineering group is responsible for all custom process equipment. The scope of work for each piece of equipment includes Requirements Definition, Procurement, Fabrication, Validation, and Change Management.
We are currently supporting a major plant expansion at Walpole MA, and construction of a new Manufacturing plant in China.
About half of the US-based Engineering group will report into this Sr. Manager
Support the Engineering teams in holding Vendors accountable for the design and fabrication of custom process equipment. Leverage GAMP-V milestones (DQ, FAT, and SAT) to verify that the vendors are achieving all of our custom requirements.
Support the Engineering teams in performing FMEA Risk Assessments to quantify risks to patient safety and the business. Influence the vendor designs to identify & implement appropriate mitigations.
Develop a risk-based validation strategy for the custom equipment and systems. Influence the local Validation Review Board to secure approval of the validation strategy.
Manage internal & contracted Validation resources to assist the Engineering teams in developing validation protocols, executing the validations, and submitting final reports.
Manage key predecessors to the Validation of the custom process equipment to include: the preparation of Calibration & Maintenance requirements, Maintenance procedures, and Operator Work instructions.
As a Senior Manager, this position manages very complex projects, to include definition, resource allocation, planning, implementation and control. Guides cross-functional initiatives to develop very complex specifications reflecting user requirements and business criteria.
Successfully defines work flows, jobs, and reporting relationships to obtain optimum effectiveness. Develops and manages department budgets and business plans for a small to medium sized department. Typically responsible for continuous improvement of existing policies, products, and methods. Identifies resource needs and may develop justification. Troubleshoots and resolves very complex problems. Responsible for overall success of function or project.
Demonstrates and applies a comprehensive knowledge of Engineering field of specialization through successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues and contributes to problem resolution.
Strong cross-functional Leadership skills. Accountable and responsible for getting things done. Able to successfully influence down, up, and across the organization. Preferably with a “Servant” or participative leadership style to help build trust, convey respect, enhance collaboration, and to place the mission & team above your own needs.
Experience procuring and validating custom process equipment. Preferably with significant experience leveraging GAMP-V principles
Experience performing design and/or process-FMEAs. Preferably with significant experience facilitating cross-functional teams in performing these risks assessments.
Experience leading successful cross-functional teams in complex projects
Experience working is a large-scale Manufacturing plant, preferably in the Medical device or Pharma industries
- BS in Engineering; MS degree is preferred
- Typically 8+ years of Engineering Management experience with responsibility & accountability for significant projects
- 20-25% in domestic and international travel is anticipated to support vendor qualifications, equipment design qualifications (DQ), factory acceptance testing (FAT), and Program reviews.
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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .