- Live and promote our values of Integrity, Partnership, Agility, Teamwork, Empowerment and Accountability, Trust, Excellence, and Caring.
- Lead, hire, train, motivate, and develop teammates.
- Create and work within budget, schedule, and scope constraints while managing risk and ensuring adherence to established processes and regulations.
- Partner with customers, suppliers, and internal resources.
- Understand and drive business issues, utilize data to solve problems, and make timely decisions.
- Demonstrate outstanding project management and organizational skills. Anticipate strategic problems and guide the team to effective resolutions.
- Demonstrate technology leadership with engineering expertise in the medical device industry.
- Invent, solve problems, and Improve the lives of patients.
- BS in Engineering or a related field (Mechanical, Biomedical, Chemical) is highly desired, or a combination of work history in the medical device field.
- A minimum of 10 years of related work experience in the medical device field.
- A minimum of 3 years of leadership experience.
- Experience working through all aspects of medical device design & development, including design verification and validation, process validation, and technology transfer.
- Must be able to function with little or no supervision.
- A Six Sigma Green/Black Belt (Preferred)
- The ability to perform statistical analysis using k-factors, Ppk, DOEs, and root cause analysis.
- Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (DFEMA), including:
- Subject matter expertise in a directly applicable sub-field (e.g., medical device development, mechanical assembly, catheter systems, injection molding, extrusions, electro-mechanical, etc.) (Preferred).
- Development of reinforced shafts and sheaths, including steerable catheters. (Preferred)
- Proficiency in solid 3-D modeling (i.e., SolidWorks) (Preferred).
- Design for manufacturability and assembly (DFMA).
- Creation of risk assessments & failure mode element analysis (RA/FMEA).
- Must have experience with medical process validation, including:
- Supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA).
- Root cause analysis and structured problem-solving.
- Experience and understanding of the design of plastics injection mold fabrication processes.
- The ability to perform statistical analysis to ensure quality output of components & assemblies.
- High initiative and flexibility in adapting to changing needs in a dynamic work environment.
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Sr. Engineering Manager – New Product Development - Brooklyn Park, United States - Biomerics
Description
Company Overview: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships with customers and our team members.
JOB DESCRIPTION:
The Sr Engineering Manager will be responsible for leading the development of medical devices in a dynamic, customer-focused organization. You will manage and direct a team of engineers and work with customers to develop design input specifications. You and your team will design, build, and test devices to those specifications. Cross-functional leadership, proper design control and documentation, and contributing to a world-class corporate culture are critical requirements. Our NPD team takes on various program types and successfully launches them into our manufacturing operations.
JOB RESPONSIBILITIES:
JOB REQUIREMENTS:
Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, On-Site Fitness Facility.
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).
The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.
Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.
