Engineering Jobs in Middleton
30 positions found — Page 2
Location: Waunakee, WI
Type: Full-Time
About the Role:
We are seeking a detail-oriented and proactive Material Planner to ensure a continuous supply of materials in support of our manufacturing schedules. This role manages purchase orders, internal production orders, and inventory to meet company objectives while collaborating with internal teams and external suppliers.
What You’ll Do:
- Supply ship dates for Sales Orders impacted by parts shortages.
- Maintain material master data, safety stock levels, and forecasts for all facilities in the U.S.
- Maintain planning system integrity and optimize parameters relative to material planning data.
- Ensure accurate purchase order (PO) dates are maintained and updated in MRP system.
- Create and release internal production orders to manufacture parts locally.
- Communicate, resolve, and expedite delays in material receipts with relevant departments.
- Order Airfreight components from internal suppliers for material shortages within company guidelines.
- Research, investigate, and resolve purchase order (PO) receipt and shipping discrepancies.
- Interact and collaborate with internal suppliers, manufacturing, sales, engineering, warehousing, logistics, and accounting.
- Prepare inventory and performance reports.
What We’re Looking For:
- Bachelor’s degree in Business, Supply Chain, or related field preferred; APICS certification a plus.
- Minimum 3 years of experience in material planning or related field.
- Strong planning, organizational, and problem-solving skills.
- Proficiency in MS Excel; SAP or other ERP experience preferred.
- Customer service mindset with excellent communication skills.
- Self-motivated, able to work independently, and detail-oriented.
Physical Requirements:
- Ability to sit or stand for prolonged periods and lift up to 50 pounds.
Why Join Us:
- Be part of a high-performing, collaborative team where your contributions directly impact our manufacturing efficiency and customer satisfaction.
- Collaborate across multiple departments, gaining exposure and building a strong foundation for career advancement.
- Work in a dynamic and supportive environment that values continuous improvement, innovation, and professional development.
- Access to training programs to enhance your skills and advance your career.
- Competitive salary, benefits package, and opportunities to be recognized for your contributions.
- Play a key role in keeping our products moving and customers happy, making a real difference every day.
Project Management Duties:
- Develops a cost-effective plan and schedule for completion of project following a logical pattern for utilization of resources.
- Coordinates work of subcontractors working on various phases of multiple projects.
- Oversees performance of all trade contractors and reviews architectural and engineering drawings to make sure that all specifications and regulations are being followed.
- Is responsible for proper administration of construction contracts and for obtaining all necessary permits and licenses.
- Supervises assistant managers and superintendents, reviews their reports, checks on any reported difficulties, and corrects any safety violations or other reported deficiencies.
- Tracks and controls construction schedule and associated costs to achieve completion of projects within time and monies allocated.
- Reports to owner, architects and portfolio managers about progress and any necessary modifications of plans that seem indicated. Plans, implements, tracks and closeout / turnover of construction projects. Conducts project meetings.
- Manages day to day operational and tactical aspects of multiple construction projects in a supervisory role
- Manages day to day client interactions and expectations, directly or in a supervisory role
- Accurately forecasts revenue, profitability and project costs
- Manages to and achieves revenue goals set for projects
- Generates and issues regular internal and external project reporting through company software
Requirements:
- 4+ years of experience managing commercial construction projects.
- Multi-family, large commercial, and/or industrial project experience is preferred.
- Associates or Bachelors Degree in Construction Management or related field is a plus.
COMPANY
Terra Engineering & Construction Corporation is a civil construction company specializing in earth retention, drilling, deep foundations, dams, watercourse and marine work, underground utilities, excavating and grading. Terra also provides engineering/design build services for earth retention and deep foundation structures.
GENERAL DESCRIPTION
Terra Engineering & Construction Corporation, an employee-owned company, has an opportunity for a Project Manager/Estimator based out of Madison, WI. This position will provide project management for all aspects of civil and foundation construction. This position will have some local and regional travel.
DUTIES & RESPONSIBLITIES
The specific responsibilities of the Project Manager/Estimator include, but are not limited to, the following:
- Understand the terms and scope of the construction contract
- Coordinate subcontractor activities
- Track material, production, and project costs
- Quality control and adherence to specifications.
- Corresponding and negotiating with the Owner and Fed/Local Agencies
- Maintain project schedule
- Attend construction related meetings to support project related functions
- Leading, mentoring and managing staff
- Material and Subcontract negotiations and purchasing
- Estimating, take‐offs, solicit quotes
- Promote safety – assist with the implementation of all applicable HSE programs, policies and procedures
- Other duties as needed
QUALIFICATIONS
· B.S in Civil Engineering with 5+ years of experience
· P.E. and/or project management experience in civil and foundations construction preferred
· Ability to handle multiple projects at one time and manage tight deadlines
· Ability to successfully negotiate terms and conditions
· Excellent verbal and written communication to collaborate with internal and external stakeholders
· Strong attention to detail
· Computer software proficient, specifically with estimating and job cost tracking software
SALARY RANGE
Terra offers a competitive salary range from $105,000 to $140,000 annual salary.
BENEFITS
Terra offers a competitive benefits package, including:
· ESOP Ownership
· 401K
· Health, Dental, Life Insurance
· Flexible Spending Accounts
· Long- and Short-Term Disability
· Paid Holidays, Vacation and Sick Leave
TO APPLY
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An Equal Opportunity/Affirmative Action Employer
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Many JOPP graduates achieve offers in the $90,000 to $154,000 range depending on their role focus and skill coverage.
Our purpose is to align your skills and profile with what employers are hiring for right now—so you get responses, interviews, and offers.
Why you may not be getting replies Your resume lacks stack clarity (recruiters can't quickly see your fit) Projects look like tutorials (no depth, no real-world features, no measurable outcomes) Skills are scattered (no coherent narrative: "What role are you targeting?”) You're missing job-market staples (Git, CI/CD basics, APIs, cloud exposure, SQL) You're not speaking the language of the job description SynergisticIT approaches this from both angles: build real skills and build a market-ready profile.
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Officer None
What to Expect
Information Professional Officer
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Responsibilities
Information Professional Officers (IPOs) oversee the seamless operation of the global Naval network environment. Their responsibilities include:
- Leading the Naval network warfare missions in developing tactics and procedures to realize tactical, strategic and business advantages afloat and ashore
- Driving interoperability with joint, allied and coalition partners
- Building professional excellence through education, training and certification and milestone qualifications
- Optimizing organizational effectiveness through cutting-edge technologies, knowledge management techniques and a culture of innovation
- Helping to develop and deploy information systems, command and control and space systems
- Serving as a key part of the Information Dominance Corps in its mission to gain a deep understanding of the inner workings of adversaries
- Overseeing the work of Information Systems Technicians - Enlisted Sailors (no degree required) who serve as specialists in information technology
Work Environment
Information Professionals serve in challenging roles of increasing scope and responsibility both afloat and ashore. This could include:
- Serving as part of Battle Group staffs on ships at sea
- Working in C4I/Space/Surveillance on shore tours
- Serving on major Navy and joint staffs
- Serving in command of key communication and surveillance facilities around the globe
Training & Advancement
Those pursuing an Information Professional Officer position are required to attend Officer Candidate School (OCS) in Newport, RI.
Upon completion, candidates typically attend a five-week IP Basic Course of instruction in Pensacola, FL, before or during their initial assignment. IPOs must complete specific qualifications as part of their training during Fleet tours and are expected to pursue advanced education opportunities.
Promotion opportunities are regularly available but competitive and based on performance.
Post-Service Opportunities
Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in related fields in the civilian sector.
Education Opportunities
Wherever you are in your professional career, the Navy can help ease your financial burdens and advance your career with generous financial assistance and continuing education programs. Beyond professional credentials and certifications, Information Professional Officers can advance their education by:
- Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
- Completing Joint Professional Military Education (JPME) at one of the various service colleges
Postgraduate education is important to the success of the Information Professional. Most IPs will complete a master's degree in C4I, space, information systems, computer science or modeling and simulation.
There's also potential to pursue a graduate certificate, DoW certifications, federal executive fellowships and information assurance scholarships and internships.
Qualifications & Requirements
A degree from a four-year college or university is a minimum educational requirement to become a Commissioned Officer. Candidates seeking an Information Professional Officer position must have a bachelor's degree from a regionally accredited institution in a technical field, preferably in one of following fields: Information Systems, Electrical Engineering, Computer Engineering, Information Operations, Computer Science, Systems Engineering, General Engineering.
All candidates must also be: U.S. citizens, willing to serve worldwide, eligible for a Top Secret/Sensitive Compartmented Information (SCI) security clearance and qualified for sea duty.
General qualifications may vary depending upon whether you're currently serving, whether you've served before or whether you've never served before.
Part-Time Opportunities
There are part-time opportunities available as an Information Professional Officer.
Serving part-time as a Navy Reserve Sailor, your duties will be carried out during your scheduled drilling and training periods. During monthly drilling, Information Professional Officers in the Navy Reserve typically work at a location close to their homes.
For annual training, Information Professional Officers may serve anywhere in the world, whether on a ship at sea or at bases and installations on shore.
Take a moment to learn more about the general roles and responsibilities of Navy Reserve Sailors.
Most of what you do in the Navy Reserve is considered training. The basic Navy Reserve commitment involves training a minimum of one weekend a month (referred to as drilling) and two weeks a year (referred to as Annual Training) - or the equivalent of that.
Information Professional Officers in the Navy Reserve serve in an Officer role. Before receiving the ongoing professional training that comes with this job, initial training requirements must first be met.
For current or former Navy Officers (NAVET): Prior experience satisfies the initial leadership training requirement - so you will not need to go through Officer Training again.
Officers who previously held a commission in another United States Military Service, National Oceanic and Atmospheric Administration, Public Health Service, or United States Coast Guard are exempt from attending ODS or LDO/CWO Academy.
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Officer None
What to Expect
Surface Warfare Officer
More Information
Responsibilities
Surface Warfare Officers (SWOs) are involved in virtually every aspect of Navy missions. As a SWO, you may be in charge of any number of shipboard operations and activities while at sea, working with or within any of these specialized forces:
Aircraft Carrier Forces: Provide and coordinate air, submarine and surface ship defense for aircraft carriers.
Cruiser-Destroyer Forces: Provide ship attack and defensive measures with a wide array of missile and fire power capabilities, providing anti-air, -submarine and -surface warfare support.
Amphibious Forces: Embark and transport vehicles, equipment and personnel for amphibious assault operations.
Combat-Logistics Forces: Provide combatant ships with fuel, ammunition, food and supplies, and provide repair, maintenance and rescue capabilities through Fleet Support Ships.
Mine Warfare Forces: Detect, identify and neutralize threats from hostile use of maritime mines.
You may also be interested in becoming a Surface Warfare Officer within the prestigious Navy Nuclear community where you will have the opportunity to work on some of the world's most powerful nuclear-powered submarines and aircraft carriers.
Work Environment
As a Surface Warfare Officer, you will work at sea and on shore, in a variety of environments. Sea duty could place you aboard ships within the fleet. Shore duty may involve a tour of duty at the Pentagon, a student assignment at the Naval Postgraduate School in Monterey, CA, or command and management positions at shore bases and stations around the world.
Training & Advancement
Those pursuing an Information Professional Officer position are required to attend Officer Candidate School (OCS) in Newport, RI.
Unless they have already been commissioned through the Naval Academy or ROTC, those pursuing a Surface Warfare Officer position are required to attend Officer Candidate School. Newly commissioned SWOs can expect an advanced training process that includes comprehensive training at sea and ashore.
Newly commissioned Surface Warfare Officers will be assigned to a surface ship, leading a team of Sailors responsible for a component of the ship - anything from electronics to weapons to engineering systems. In this setting, Officers are working toward full Surface Warfare qualification.
After completing these initial sea tours, Surface Warfare Officers may be selected to serve on high-level staffs, commands or strategic projects or they may be selected to work in recruitment. The ultimate goal for many: to one day command their own ship.
Promotion opportunities are regularly available but competitive and based on performance.
Post-Service Opportunities
Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in related fields in the civilian sector.
Education Opportunities
Wherever you are in your professional career, the Navy can help ease your financial burdens and advance your career with generous financial assistance and continuing education programs. Beyond professional credentials and certifications, Surface Warfare Officers can advance their education by:
- Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
- Completing Joint Professional Military Education (JPME) at one of the various service colleges
Qualifications & Requirements
A degree from a four-year college or university is a minimum educational requirement to become a Commissioned Officer.
There are different ways to become a SWO. If you're a high school student or an undergraduate, you can enter through the Naval Reserve Officers Training Corps (NROTC) or through the U.S. Naval Academy. Those already having a degree attend Officer Candidate School (OCS), a 12-week Navy school in Newport, RI.
All candidates must also be U.S. Citizens.
General qualifications may vary depending upon whether you're currently serving, whether you've served before or whether you've never served before.
Part-Time Opportunities
There are part-time opportunities available as a Surface Warfare Officer.
Serving part-time as a Navy Reserve Sailor, your duties will be carried out during your scheduled drilling and training periods. During monthly drilling, Surface Warfare Officers in the Navy Reserve typically work at a location close to their homes.
For annual training, Surface Warfare Officers may serve anywhere in the world, whether on a ship at sea or at bases and installations on shore.
Take a moment to learn more about the general roles and responsibilities of Navy Reserve Sailors.
Most of what you do in the Navy Reserve is considered training. The basic Navy Reserve commitment involves training a minimum of one weekend a month (referred to as drilling) and two weeks a year (referred to as Annual Training) - or the equivalent of that.
Surface Warfare Officers in the Navy Reserve serve in an Officer role. Before receiving the ongoing professional training that comes with this job, initial training requirements must first be met.
For current or former Navy Officers (NAVET): Prior experience satisfies the initial leadership training requirement - so you will not need to go through Officer Training again.
Officers who previously held a commission in another United States Military Service, National Oceanic and Atmospheric Administration, Public Health Service, or United States Coast Guard are exempt from attending ODS or LDO/CWO Academy.
Compare Navy Careers
See how a career as a Surface Warfare Officer compares to other Navy jobs.
Compare roles, pay and requirements for each job now.
Johnson Health Tech (JHT) is expanding its innovation efforts in hearing technology and is seeking a Senior Product Owner to help shape the next generation of hearing device solutions.
This role sits within JHT's global R&D organization and plays a key role in defining how new hearing technologies are brought to life. Working closely with engineering, audiology, marketing, and business leaders, including the SyncLync team, this individual will translate product vision into actionable development plans that guide engineering teams from concept through delivery.
This is a high-impact product leadership role focused on innovation, cross-functional collaboration, and delivering meaningful advancements in hearing technology.
Position Overview:
Reporting to Johnson Health Tech's R&D organization, the Senior Product Owner will translate product strategy into clear development priorities and guide cross-functional teams in delivering hearing device features and capabilities.
This individual will work closely with product managers, engineers, and global stakeholders to define minimum viable products (MVPs), manage development backlogs, and ensure teams build features that deliver the highest value to customers and the business.
Success in this role requires strong communication, strategic thinking, and the ability to navigate complex technical development environments while maintaining alignment across multiple stakeholders.
Key Responsibilities:
Product Strategy & Vision Translation
- Translate product vision into clear feature definitions, user stories, and tactical development plans
- Collaborate with product managers and business partners to shape product strategy and long-term roadmaps
- Help define minimum viable product (MVP) scope and prioritize features based on business value and customer needs.
Agile Development Leadership
- Own and manage the product backlog, including grooming, prioritization, and refinement
- Ensure development teams have clear requirements, acceptance criteria, and success metrics
- Participate in sprint planning, demos, and retrospectives to support continuous improvement
Cross-Functional Collaboration
- Work closely with engineering, audiology, marketing, quality, and manufacturing teams to ensure alignment
- Facilitate communication between business stakeholders and development teams
- Identify and remove barriers that may impact product delivery
Product Delivery & Performance
- Monitor key performance indicators (KPIs) and ensure product features meet quality and performance expectations
- Evaluate feasibility, cost implications, and development tradeoffs during product planning
- Support product launches by coordinating testing, training, and operational readiness
Team Leadership & Mentorship
- Mentor team members and contribute to product development best practices
- Promote strong collaboration and alignment across global teams
- Help drive a culture of accountability, transparency, and continuous improvement
Requirements:
Education
- Bachelor's degree in Engineering, Computer Science, Information Systems, or a related field
- MBA or advanced degree preferred
Experience
- 5+ years of experience as a Product Owner or Product Manager working within Agile development environments
- Proven experience translating product vision into development requirements and backlogs
- Experience working closely with engineering teams delivering complex technology products
- Knowledge of electrical hardware systems or system integration is a plus
Skills & Leadership Attributes
- Strong communication and stakeholder management skills
- Ability to influence cross-functional teams and align diverse groups around shared goals
- Excellent analytical, organizational, and problem-solving abilities
- Comfortable making decisions and prioritizing work in fast-moving development environments
- Strong experimental mindset and ability to drive innovation amidst uncertainty
Additional Details
- Based in Cottage Grove, WI
- Reports directly to JHT VP of R&D
- Ability to travel domestically and internationally (~4x per year)
- Willing to collaborate across global time zones
Job Title - Project Manager
Location - Madison, WI - Hybrid
Duration - 12+ Months
Project to be assigned:
1. Reinsurance Modernization, workstreams include:
· migration of reinsurance contracts and history from Prosume and DWH into Duck Creek
· delivery of functional changes in Duck Creek, adoption of a new version of the platform
· changes to global reinsurance sub-systems to handle NAO data and integrations to GL,
earnings engine, payment processing
· business process
· reporting
· Integration of gross policy and loss data
· Technical services
This is expected to be full time PM.
Day In The Life of Contractor
What will this person be doing every day?
Please see job description. This is an IT Program Manager position. The person needs to drive delivery
of key initiatives supporting our business. This involves working with business/IT and potentially
outside vendors to perform all aspects of a Program Manager role, e.g.:
2. develop a project plan
3. drive the team towards those milestones
4. track issues/risks/dependencies
5. develop budgets and track forecasts
6. develop and deliver team and senior stakeholder communication
Technical Skills and Experience
What are the top 3 - 5 must have technical skills?
7. Proven experience delivering complex initiatives
8. Proven experience with Agile/Agile Methodologies and delivering projects leveraging this
framework
9. Extremely proficient with MS Office Apps – MS Project, PowerPoint, Excel, Word
10. Very good financial skills, i.e., creating budgets, forecasts, cost-benefit analyses, etc. 11. Proven experience working with vendors 12. Insurance experience required, P&C and reinsurance knowledge preferred Soft Skills and Team Fit What soft skills are you looking for? 13. Ideal candidates need to have proven experience leading business-driven projects 14. Excellent stakeholder management skills across Business, IT, and teams 15. Excellent oral and written communication skills, including PowerPoint Resumes If you've hired someone in a similar or the same position, what do you like to see on a candidate resume? Work experience with companies? Technology, proven experience. Likes/Dislikes? What has stood out good/bad about previous candidates? 16. Need to see a mix of IT and Business driven projects on their resume. 17. Proven experience with Agile 18. Insurance industry experience required 19. The resume needs to be well-written as the person needs to have good communication skills – no typos, grammatical errors, etc. In the past, we have received too many resumes with clear typos and other issues. 20. Resume should be no longer than 3 pages – hiring manager will not review any resumes longer than 3 pages and 2 pages is preferred. Clear and concise communication must be demonstrated. Interview Process Tell me about your interview process? Will there be a technical phone screen? Will there be a panel? For in-person interviews, how large is the group of interviewers? N/A 21. Round 1: Candidates will first interview with hiring manager (~45 minutes) 22. Final Round: Interview with IT and /or Business Stakeholders (~30-45 minutes) All interviews will likely be virtual on Teams unless candidate is based in Madison or NY.
Job Title: Staff Manufacturing Engineer
Department: Manufacturing Engineering
Employment Type: Full-time
About NeuWave
NeuWave Medical develops image guided microwave ablation tools and software that enables physicians to treat tumors in a minimally invasive procedure. This technology allows patients to be treated in outpatient settings, reducing procedural complexity and recovery times. Our organization is excited to be embarking on numerous new development projects to further improve patient care, and we are looking for new teammates to help us on this inspired journey. You’ll join an interdisciplinary group of engineers who work closely with manufacturing, quality, regulatory, clinical, and strategic marketing professionals. This team highly values rapid experimentation and close collaboration with clinicians. Our culture blends friendly competition with genuine camaraderie—we move quickly, celebrate wins, and build lasting relationships while shaping the future of the business.
As part of NeuWave, you’ll have access to a comprehensive offering of competitive benefits. If you’re motivated by clinically meaningful problems, evidence driven development and building solutions at scale, NeuWave offers the chance to perform career defining work--with freedom to develop yourself within a progressive and growing healthcare company.
Position Summary
The Staff Manufacturing Engineer will provide process engineering and controls support to develop, transfer, optimize, and sustain manufacturing processes for medical device manufacturing in an ISO 13485 compliant setting. Ensure projects meet all required quality, cost, capacity and regulatory requirements while adhering to company policy and best industry practices.
Key Accountabilities
- Support Design Transfer from R&D to manufacturing: define processes, tooling, test methods, cell layout, and work instructions.
- Develop and improve manufacturing processes and Work Instructions using continuous improvement methodologies.
- Own NC/CAPA records related to production components/processes and drive corrective and preventative action plans to completion.
- Build business cases to implement new technologies and applications which streamline business processes, including Machine Learning, Artificial Intelligence tools, record digitization, automated test data collection, vision systems, ect.
- Establish working relationships with component manufacturers and provide technical feedback as required.
- Documentation & training: create process documentation, training materials, and guide technicians/operators through implementation.
- Design test methods to ensure process/product quality.
- Provide technical direction and leadership to project team members in investigation and experimentation efforts aimed at practical applications of scientific theories or principles
- Provide technical leadership to product development team
- Provide support as a Subject Matter Expert during internal/external audits for Quality and Regulatory Compliance.
- Provides complex design reviews and feedback for improvements in manufacturability.
Education, Experience & Skills
- Bachelor’s degree in Industrial, Mechanical, Electrical, Software Engineering, or a related field preferred; equivalent direct experience will also be considered.
- Typically 4–8 years’ experience with mechanical/electrical manufacturing processes, including assembly and testing.
- Medical device manufacturing experience.
- Experience leading cross functional project teams or supervising staff is desirable.
- DFMEA (design failure mode effect analysis) principles, PFMEA (process failure mode effect analysis) principles, AFMEA ((application) failure mode effect analysis) principles.
- Working knowledge of mechanical testing of systems, sub-systems, and components.
- Knowledge of intellectual property fundamentals and legal processes for managing intellectual art.
Physical Requirements
- Sit or stand for 8-10 hours per day.
- Lift up to 20 lbs.
Location
This position will be based in Madison, WI with ~10-20% domestic and international travel.
Equal Opportunity Employer
NeuWave Medical is an equal opportunity employer. We are committed to creating an inclusive environment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.
Job Title: Associate Director QARA
Department: Quality
Reports to:
Employment Type: Non-exempt
About NeuWave
NeuWave Medical develops image guided microwave ablation tools and software that enables physicians to treat tumors in a minimally invasive procedure.This technology allows patients to be treated in outpatient settings, reducing procedural complexity and recovery times. Our organization is excited to be embarking on numerous new development projects to further improve patient care, and we are looking for new teammates to help us on this inspired journey. You’ll join an interdisciplinary group of engineers who work closely with manufacturing, quality, regulatory, clinical, and strategic marketing professionals. This team highly values rapid experimentation and close collaboration with clinicians. Our culture blends friendly competition with genuine camaraderie—we move quickly, celebrate wins, and build lasting relationships while shaping the future of the business.
As part of NeuWave, you’ll have access to a comprehensive offering of competitive benefits. If you’re motivated by clinically meaningful problems, evidence driven development and building solutions at scale, NeuWave offers the chance to perform career defining work--with freedom to develop yourself within a progressive and growing healthcare company.
Position Summary
NeuWave is seeking a dynamic Associate Director of Quality Assurance & Regulatory Affairs (QA/RA) to lead and scale our quality and regulatory functions during a critical phase of transition and innovation. This role is responsible for establishing and maintaining compliant quality systems (ISO 13485, 21 CFR 820), overseeing regulatory approvals, leading audits, ensuring product safety, and partnering cross-functionally with R&D and Operations.
The Associate Director will drive a strong quality culture while overseeing full-time and contract staff across New Product Development & Lifecycle Quality, Quality Systems, Production & Service Quality, Supplier Quality, and Post-Market Surveillance. A key focus will be leading major transition initiatives, including standing up a new Quality System, implementing a new eQMS, and executing the 2025 functional business plan.
Key Accountabilities
- Lead and maintain a compliant Quality Management System (QMS) aligned with FDA, ISO 13485, EU MDR, and global regulatory standards; drive achievement of key quality metrics, including CAPA effectiveness.
- Oversee major transition initiatives, including implementation of a new QMS, eQMS deployment and validation, and migration of legacy quality systems.
- Serve as primary liaison to regulatory authorities (FDA, EU Notified Bodies); lead regulatory submissions, registrations, labeling compliance, and responses to inquiries.
- Ensure audit readiness and lead internal, third-party, and regulatory audits, including TÜV surveillance audits.
- Oversee product and lifecycle quality, including risk management, design controls, production quality, and post-market surveillance.
- Partner with R&D and Operations to support successful new product introductions and define regulatory pathways.
- Strengthening supplier quality and manufacturing performance, driving operational efficiency and Cost of Goods (COGs) improvements.
- Build and lead a high-performing QA/RA team while advancing a strong, business-aligned quality culture.
Education, Experience & Skills
- Education: Bachelor’s degree in Engineering, Science, or related field required; advanced degree preferred.
- Experience: 5+ years in QA/RA within regulated industries, including leadership experience.
- Regulatory Expertise: Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and global submission processes (510(k), PMA, EU MDR).
- Leadership: Proven ability to lead cross-functional quality teams across production, systems, and post-market activities.
Location
This position will be based in Madison, Wi. Relocation assistance may be available for the preferred candidate.
Equal Opportunity Employer
NeuWave Medical is an equal opportunity employer. We are committed to creating an inclusive environment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.
