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Full-time
bachelor degree
Posted 2d ago
~40 hrs/week
Responsibilities
Lead and develop a multi-disciplinary engineering department focusing on manufacturing, mechanical engineering, and automation. Drive strategic projects to improve safety, quality, and cost while ensuring regulatory compliance and managing capital investments.
Requirements
Requires a Bachelor of Science in Mechanical Engineering with at least 10 years of manufacturing experience and 3-5 years of leadership experience. Experience with medical devices, FDA/ISO regulations, and phased product development is highly preferred.
Full job description
About Aspen
We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.
Summary
The Senior Engineering Manager is responsible for building, leading, and developing a high-performing engineering department spanning multiple disciplines:
Manufacturing/Mechanical Engineering
Injection Molding
Controls / Automation
Project Management
In This Position, You Will Have the Opportunity To
Build and Develop Engineering team capabilities to align with company objectives.
Recommend and prioritize strategic projects that impact Safety, Quality, Delivery, Cost, Morale, and the Environment.
Drive accountability by owning engineering team outcomes, setting realistic goals, removing blockers, and ensuring the team delivers, quality on time results.
Recommend and implement creative solutions to improve engineering Quality System in compliance with regulatory requirements.
Recommend Capital investment where applicable and manage forward looking CapEx requirements.
Responsible for auditing and improving run rate standards
Represent engineering functions for regulatory audits (FDA, Notified body, etc).
Further develop and grow a culture of positivity, teamwork, solution delivery and collaboration.
Negotiate directly with the internal business customers to resolve priority issues.
Report regularly to Aspen Leadership Team on status of projects.
Provide oversight to ensure designs meet the product requirements and to remediate design and component problems that are discovered after product launch.
Provide a safe work environment by ensuring that products are designed for safe manufacturability, as well as usage by customers.
Participate in Risk Assessments and FMEA’s to ensure customer specifications and design intents are adhered to.
Manage remediation needs of the business to assure that product files are compliant to the regulations.
What You Need to Succeed in This Position
Bachelor of Science degree in Mechanical Engineering required with 10 yrs. of relevant manufacturing experience
Minimum of 3 - 5 years leadership in Engineering required.
Medical Device or related industry experience that includes FDA and ISO requirements is a plus
Strong project management capabilities to drive on time schedule adherence and communication.
Demonstrated business acumen, with the ability to connect engineering work to customer impact, organizational priorities, and measurable outcomes.
Excellent communication skills with the ability to explain priorities clearly, listen well, and adapt the message for engineers, executives, and cross-functional partners
Coaching mindset, with the ability to deliver constructive feedback and foster professional growth and development within the team.
Proven ability to attract, develop, and retain top engineering talent to meet evolving business needs.
Thorough understanding and consistent application of company policies, procedures, programs, and regulatory requirements, with an unwavering commitment to the Corporate Code of Ethics and Standards of Conduct.
Experience managing in a matrix organization working with high production volume medical device disposables.
Familiarity with customer needs analysis methodologies such as VOC
Experience with requirements, and requirements management (i.e. Design Input / Output)
Proficiency with phased product development processes, stage-gate project management, etc.
Demonstrated ability to develop effective working relationships with cross functional personnel, both internally and externally.
Physical Requirements:
NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.
Related keywords
Medical DeviceFDAISOInjection MoldingAutomationFMEAVOCDesign InputDesign OutputCapExQuality SystemManufacturingMechanical EngineeringProject ManagementStage-GateRegulatory Audits
We provide clinicians with tools to advance the entire perioperative experience.
Industry
Medical Equipment Manufacturing
Company size
1,001-5,000 employees
Founded
1999
Headquarters
Caledonia, MI
LinkedIn followers
13,423
Founded in 1999, Aspen Surgical is a leading medical device manufacturer that provides clinicians with tools to enhance the entire perioperative experience.
Aspen Surgical offers an expanding portfolio of surgical tools and solutions, as well as trusted brands that ensure consistent performance day after day, including Bard-Parker®, Bovie®, Bookwalter®, Olsen®, and more. Their high-quality products are designed with precision to meet the stringent demands of the perioperative environment.
Headquartered in Caledonia, Michigan, and extending its global footprint in Las Piedras, Puerto Rico; Agua Prieta, Mexico; and Cheltenham, Australia, Aspen Surgical stands at the forefront of trusted performance at all points of care.
For an in-depth look at products and the Aspen Surgical community, visit www.aspensurgical.com.
Offices: 6945 Southbelt Dr. SE, Caledonia, MI 49546, US · PO Box 2007 Road 183 Km 20.3, Las Piedras, Puerto Rico 00771, PR · Calle 15 Avenida 6 a la 10, Agua Prieta, Mexico 84200, MX · 4/47 Wangara Road, Cheltenham, VIC 3192 , AU
ManufacturingPackagingDistributionSales & MarketingNew Product DevelopmentQuality AssuranceOperationsSupply Chainand Continuous ImprovementHealth Care
We provide clinicians with tools to advance the entire perioperative experience.
Industry
Medical Equipment Manufacturing
Company size
1,001-5,000 employees
Founded
1999
Headquarters
Caledonia, MI
LinkedIn followers
13,423
Founded in 1999, Aspen Surgical is a leading medical device manufacturer that provides clinicians with tools to enhance the entire perioperative experience.
Aspen Surgical offers an expanding portfolio of surgical tools and solutions, as well as trusted brands that ensure consistent performance day after day, including Bard-Parker®, Bovie®, Bookwalter®, Olsen®, and more. Their high-quality products are designed with precision to meet the stringent demands of the perioperative environment.
Headquartered in Caledonia, Michigan, and extending its global footprint in Las Piedras, Puerto Rico; Agua Prieta, Mexico; and Cheltenham, Australia, Aspen Surgical stands at the forefront of trusted performance at all points of care.
For an in-depth look at products and the Aspen Surgical community, visit www.aspensurgical.com.
Offices: 6945 Southbelt Dr. SE, Caledonia, MI 49546, US · PO Box 2007 Road 183 Km 20.3, Las Piedras, Puerto Rico 00771, PR · Calle 15 Avenida 6 a la 10, Agua Prieta, Mexico 84200, MX · 4/47 Wangara Road, Cheltenham, VIC 3192 , AU
ManufacturingPackagingDistributionSales & MarketingNew Product DevelopmentQuality AssuranceOperationsSupply Chainand Continuous ImprovementHealth Care