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Want to learn more about MercyOne Waterloo OB/GYN Ste G4500? MercyOne Waterloo OB/GYN Ste G4500 | MercyOne

Join the MercyOne Family! We are looking to hire a Clinic RN in our MercyOne Waterloo OB/GYN Ste G4500 Clinic

As a Clinic RN  at MercyOne, you will provide patient care in outpatient settings and are responsible for delivering safe, effective, and evidence-based patient care through assessment, planning, implementation, and evaluation. They coordinate care provided by other clinical staff, support patient and family education, and ensure communication across healthcare teams. They are accountable for clinical standards and may operate with minimal supervision

Schedule:

• M-T 7:30a-4:30p
• Friday 7:30-4:30
• Full time 32 hours a week
• No Weekends no holidays

General Requirements:

• Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
• Plans, assesses, intervenes, and provides direct patient care using critical thinking and nursing processes (assessment, planning, implementation, evaluation).
• Performs comprehensive patient assessments (physical, psychosocial, nutritional, functional, safety, spiritual, cultural, educational). Makes nursing decisions based on patient status and care needs.
• Administers medications and treatments safely via multiple routes (oral, IM, SC, ID, IV, inhalation, topical, ocular, optic, sublingual, nasal) and documents accordingly.
• Performs nursing care, lab and diagnostic tests, specimen collection, phlebotomy, and limited radiology procedures following policies and universal precautions.
• Assists providers with patient care, phone/mail/fax communications, scheduling, consents, admissions, referrals, and outpatient procedures.
• Communicates and collaborates with physicians, staff, patients, families, and interdisciplinary team members regarding care plans and patient needs.
• Educates patients, families, and clinical staff on treatments, medications, test preparation, discharge, and health maintenance; documents education and evaluates understanding.
• Participates in staff meetings, committees, quality improvement, risk management, and performance improvement projects.
• Maintains documentation accuracy and completeness in EMR: assessments, vitals, symptoms, treatments, medications, education, charges, lab results, histories, and consults.
• Maintains and monitors supplies, equipment, medication stock, and office machines; follows maintenance and quality control protocols; reports malfunctions.
• Recognizes and responds appropriately to urgent/emergency patient needs and initiates emergency procedures.
• Other duties as needed and assigned by the manager.
• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical, and professional behavior

Education:

•  Must be comfortable operating in a collaborative, shared leadership environment.
• Active RN License in the state of Iowa; Licensure from other states may be required based on location. Compact State License acceptable where applicable.
• Basic Life Support (BLS) certification required within 3 months of hire.
• Proof of completion of Mandatory Reporter abuse training specific to the population served within 3 months of hire.
• Proficient in basic computer skills (Windows environment, web-based navigation, email, MS Office).
• Ability to work with diverse groups of people in a collaborative, shared leadership environment.
• Requires the ability to read, write and understand the English language, and communicate effectively with patient, visitors, and colleagues while performing their job duties.
• Completion of specialty classes or proof of other certifications required for some roles.
• Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Want to learn more about MercyOne Waterloo OB/GYN Ste G4500? MercyOne Waterloo OB/GYN Ste G4500 | MercyOne

Join the MercyOne Family! We are looking to hire a Clinic RN in our MercyOne Waterloo OB/GYN Ste G4500 Clinic

As a Clinic RN  at MercyOne, you will provide patient care in outpatient settings and are responsible for delivering safe, effective, and evidence-based patient care through assessment, planning, implementation, and evaluation. They coordinate care provided by other clinical staff, support patient and family education, and ensure communication across healthcare teams. They are accountable for clinical standards and may operate with minimal supervision

Schedule:

• M-T 7:30a-4:30p
• Friday 7:30-4:30
• Full time 32 hours a week
• No Weekends no holidays

General Requirements:

• Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
• Plans, assesses, intervenes, and provides direct patient care using critical thinking and nursing processes (assessment, planning, implementation, evaluation).
• Performs comprehensive patient assessments (physical, psychosocial, nutritional, functional, safety, spiritual, cultural, educational). Makes nursing decisions based on patient status and care needs.
• Administers medications and treatments safely via multiple routes (oral, IM, SC, ID, IV, inhalation, topical, ocular, optic, sublingual, nasal) and documents accordingly.
• Performs nursing care, lab and diagnostic tests, specimen collection, phlebotomy, and limited radiology procedures following policies and universal precautions.
• Assists providers with patient care, phone/mail/fax communications, scheduling, consents, admissions, referrals, and outpatient procedures.
• Communicates and collaborates with physicians, staff, patients, families, and interdisciplinary team members regarding care plans and patient needs.
• Educates patients, families, and clinical staff on treatments, medications, test preparation, discharge, and health maintenance; documents education and evaluates understanding.
• Participates in staff meetings, committees, quality improvement, risk management, and performance improvement projects.
• Maintains documentation accuracy and completeness in EMR: assessments, vitals, symptoms, treatments, medications, education, charges, lab results, histories, and consults.
• Maintains and monitors supplies, equipment, medication stock, and office machines; follows maintenance and quality control protocols; reports malfunctions.
• Recognizes and responds appropriately to urgent/emergency patient needs and initiates emergency procedures.
• Other duties as needed and assigned by the manager.
• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical, and professional behavior

Education:

•  Must be comfortable operating in a collaborative, shared leadership environment.
• Active RN License in the state of Iowa; Licensure from other states may be required based on location. Compact State License acceptable where applicable.
• Basic Life Support (BLS) certification required within 3 months of hire.
• Proof of completion of Mandatory Reporter abuse training specific to the population served within 3 months of hire.
• Proficient in basic computer skills (Windows environment, web-based navigation, email, MS Office).
• Ability to work with diverse groups of people in a collaborative, shared leadership environment.
• Requires the ability to read, write and understand the English language, and communicate effectively with patient, visitors, and colleagues while performing their job duties.
• Completion of specialty classes or proof of other certifications required for some roles.
• Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Want to learn more about MercyOne Waterloo OB/GYN Ste G4500? MercyOne Waterloo OB/GYN Ste G4500 | MercyOne

Join the MercyOne Family! We are looking to hire a Clinic RN in our MercyOne Waterloo OB/GYN Ste G4500 Clinic

As a Clinic RN  at MercyOne, you will provide patient care in outpatient settings and are responsible for delivering safe, effective, and evidence-based patient care through assessment, planning, implementation, and evaluation. They coordinate care provided by other clinical staff, support patient and family education, and ensure communication across healthcare teams. They are accountable for clinical standards and may operate with minimal supervision

Schedule:

• M-T 7:30a-4:30p
• Friday 7:30-4:30
• Full time 32 hours a week
• No Weekends no holidays

General Requirements:

• Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
• Plans, assesses, intervenes, and provides direct patient care using critical thinking and nursing processes (assessment, planning, implementation, evaluation).
• Performs comprehensive patient assessments (physical, psychosocial, nutritional, functional, safety, spiritual, cultural, educational). Makes nursing decisions based on patient status and care needs.
• Administers medications and treatments safely via multiple routes (oral, IM, SC, ID, IV, inhalation, topical, ocular, optic, sublingual, nasal) and documents accordingly.
• Performs nursing care, lab and diagnostic tests, specimen collection, phlebotomy, and limited radiology procedures following policies and universal precautions.
• Assists providers with patient care, phone/mail/fax communications, scheduling, consents, admissions, referrals, and outpatient procedures.
• Communicates and collaborates with physicians, staff, patients, families, and interdisciplinary team members regarding care plans and patient needs.
• Educates patients, families, and clinical staff on treatments, medications, test preparation, discharge, and health maintenance; documents education and evaluates understanding.
• Participates in staff meetings, committees, quality improvement, risk management, and performance improvement projects.
• Maintains documentation accuracy and completeness in EMR: assessments, vitals, symptoms, treatments, medications, education, charges, lab results, histories, and consults.
• Maintains and monitors supplies, equipment, medication stock, and office machines; follows maintenance and quality control protocols; reports malfunctions.
• Recognizes and responds appropriately to urgent/emergency patient needs and initiates emergency procedures.
• Other duties as needed and assigned by the manager.
• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical, and professional behavior

Education:

•  Must be comfortable operating in a collaborative, shared leadership environment.
• Active RN License in the state of Iowa; Licensure from other states may be required based on location. Compact State License acceptable where applicable.
• Basic Life Support (BLS) certification required within 3 months of hire.
• Proof of completion of Mandatory Reporter abuse training specific to the population served within 3 months of hire.
• Proficient in basic computer skills (Windows environment, web-based navigation, email, MS Office).
• Ability to work with diverse groups of people in a collaborative, shared leadership environment.
• Requires the ability to read, write and understand the English language, and communicate effectively with patient, visitors, and colleagues while performing their job duties.
• Completion of specialty classes or proof of other certifications required for some roles.
• Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Want to learn more about MercyOne Waterloo OB/GYN Ste G4500? MercyOne Waterloo OB/GYN Ste G4500 | MercyOne

Join the MercyOne Family! We are looking to hire a Clinic RN in our MercyOne Waterloo OB/GYN Ste G4500 Clinic

As a Clinic RN  at MercyOne, you will provide patient care in outpatient settings and are responsible for delivering safe, effective, and evidence-based patient care through assessment, planning, implementation, and evaluation. They coordinate care provided by other clinical staff, support patient and family education, and ensure communication across healthcare teams. They are accountable for clinical standards and may operate with minimal supervision

Schedule:

• M-T 7:30a-4:30p
• Friday 7:30-4:30
• Full time 32 hours a week
• No Weekends no holidays

General Requirements:

• Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
• Plans, assesses, intervenes, and provides direct patient care using critical thinking and nursing processes (assessment, planning, implementation, evaluation).
• Performs comprehensive patient assessments (physical, psychosocial, nutritional, functional, safety, spiritual, cultural, educational). Makes nursing decisions based on patient status and care needs.
• Administers medications and treatments safely via multiple routes (oral, IM, SC, ID, IV, inhalation, topical, ocular, optic, sublingual, nasal) and documents accordingly.
• Performs nursing care, lab and diagnostic tests, specimen collection, phlebotomy, and limited radiology procedures following policies and universal precautions.
• Assists providers with patient care, phone/mail/fax communications, scheduling, consents, admissions, referrals, and outpatient procedures.
• Communicates and collaborates with physicians, staff, patients, families, and interdisciplinary team members regarding care plans and patient needs.
• Educates patients, families, and clinical staff on treatments, medications, test preparation, discharge, and health maintenance; documents education and evaluates understanding.
• Participates in staff meetings, committees, quality improvement, risk management, and performance improvement projects.
• Maintains documentation accuracy and completeness in EMR: assessments, vitals, symptoms, treatments, medications, education, charges, lab results, histories, and consults.
• Maintains and monitors supplies, equipment, medication stock, and office machines; follows maintenance and quality control protocols; reports malfunctions.
• Recognizes and responds appropriately to urgent/emergency patient needs and initiates emergency procedures.
• Other duties as needed and assigned by the manager.
• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical, and professional behavior

Education:

•  Must be comfortable operating in a collaborative, shared leadership environment.
• Active RN License in the state of Iowa; Licensure from other states may be required based on location. Compact State License acceptable where applicable.
• Basic Life Support (BLS) certification required within 3 months of hire.
• Proof of completion of Mandatory Reporter abuse training specific to the population served within 3 months of hire.
• Proficient in basic computer skills (Windows environment, web-based navigation, email, MS Office).
• Ability to work with diverse groups of people in a collaborative, shared leadership environment.
• Requires the ability to read, write and understand the English language, and communicate effectively with patient, visitors, and colleagues while performing their job duties.
• Completion of specialty classes or proof of other certifications required for some roles.
• Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Want to learn more about MercyOne Waterloo Cancer Care? MercyOne Waterloo Cancer Care | MercyOne

Join the MercyOne Family! We are looking to hire a Clinic RN in our MercyOne Waterloo Cancer Care  

As a Clinic RN  at MercyOne, you will provide patient care in outpatient settings and are responsible for delivering safe, effective, and evidence-based patient care through assessment, planning, implementation, and evaluation. They coordinate care provided by other clinical staff, support patient and family education, and ensure communication across healthcare teams. They are accountable for clinical standards and may operate with minimal supervision

Schedule:

• 8:30a-5:00p
• No Weekends no holidays

General Requirements:

• Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, and decisions.
• Plans, assesses, intervenes, and provides direct patient care using critical thinking and nursing processes (assessment, planning, implementation, evaluation).
• Performs comprehensive patient assessments (physical, psychosocial, nutritional, functional, safety, spiritual, cultural, educational). Makes nursing decisions based on patient status and care needs.
• Administers medications and treatments safely via multiple routes (oral, IM, SC, ID, IV, inhalation, topical, ocular, optic, sublingual, nasal) and documents accordingly.
• Performs nursing care, lab and diagnostic tests, specimen collection, phlebotomy, and limited radiology procedures following policies and universal precautions.
• Assists providers with patient care, phone/mail/fax communications, scheduling, consents, admissions, referrals, and outpatient procedures.
• Communicates and collaborates with physicians, staff, patients, families, and interdisciplinary team members regarding care plans and patient needs.
• Educates patients, families, and clinical staff on treatments, medications, test preparation, discharge, and health maintenance; documents education and evaluates understanding.
• Participates in staff meetings, committees, quality improvement, risk management, and performance improvement projects.
• Maintains documentation accuracy and completeness in EMR: assessments, vitals, symptoms, treatments, medications, education, charges, lab results, histories, and consults.
• Maintains and monitors supplies, equipment, medication stock, and office machines; follows maintenance and quality control protocols; reports malfunctions.
• Recognizes and responds appropriately to urgent/emergency patient needs and initiates emergency procedures.
• Other duties as needed and assigned by the manager.
• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical, and professional behavior

Education:

•  Must be comfortable operating in a collaborative, shared leadership environment.
• Active RN License in the state of Iowa; Licensure from other states may be required based on location. Compact State License acceptable where applicable.
• Basic Life Support (BLS) certification required within 3 months of hire.
• Proof of completion of Mandatory Reporter abuse training specific to the population served within 3 months of hire.
• Proficient in basic computer skills (Windows environment, web-based navigation, email, MS Office).
• Ability to work with diverse groups of people in a collaborative, shared leadership environment.
• Requires the ability to read, write and understand the English language, and communicate effectively with patient, visitors, and colleagues while performing their job duties.
• Completion of specialty classes or proof of other certifications required for some roles.
• Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Colleagues of MercyOne Health System enjoy competitive compensation with a full benefits package and opportunity for growth throughout the system!

Visit MercyOne Careers to learn more about the benefits, culture, and career development opportunities available to you at MercyOne Health System circle of care.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

A QC Analyst is an entry level position for individuals who use their understanding of science to perform the basic and critical experimental work of day-to-day analysis, including generation and analysis of data. Their work is “hands on” in an analytical lab and requires analytical testing, computer operating, record keeping, and report writing abilities. This position performs the quality testing needed for raw material, in-process, finished goods, stability, and cleaning validation analysis, while following all regulations and SOP’s.

Duties may include but are not limited to:

• Perform efficient/reliable/high quality analytical testing in accordance with USP/NF/EP/JP/FCC/etc. or customer supplied guidelines. Typical testing may include Dissolution, Titration, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC, etc.

• Maintain accurate written records of all analysis performed.

• Accurately interpret and effectively communicate analytical results and issues.

• Schedule daily tasks in an organized and efficient manner.

• General knowledge of the use and operation of basic laboratory equipment.

• Calibrate and maintain lab equipment and instrumentation.

• Responsible for operating in a safe manner, must be familiar with basic laboratory and chemical hygiene practices

• Become proficient in standard operating procedures and test methods.

• Ability to work in a “flow to the work” team environment.

• In combination with other lab personnel, be responsible for a clean and safe work environment.

• Perform peer review of analytical testing and write up.

• Write SOPs on an as needed basis.

• Other duties as required in support of Catalent Pharma Solutions high performance

Education or Equivalent Requirements:

Minimum education required to perform the job:

• Bachelor’s degree in a scientific field.

• Alternate degrees in a non-scientific field may be accepted with at least 2 years of relevant experience in a material testing laboratory.

Knowledge/Skills Requirements:

Minimum skills/knowledge required to perform job:

• Ability to multi-task with high efficiency.

• Ability to work well under pressure, maintain efficiency, and meet deadlines.

• Proficient in English. Ability to communicate effectively.

• Basic knowledge of lab safety and the ability to work safely with chemicals of varying potency.

• General computer literacy including use of Microsoft Word and Excel.

• Ability to perform analytical testing while standing for long periods of time

• Accurate testing on the first attempt under pressure of production details.

• Experience in the pharmaceutical industry preferred.

Preferred Qualifications:

Desirable skills, knowledge and/or experience that enhance job performance

• Bachelor’s degree in Chemistry or Biology

• Work Experience – 2 – 5 years in Quality, Laboratory, Clinical or Chemical manufacturing role (including internships or co-op experience).

*SHIFT - SAT, SUN & MON 6AM - 6PM & EVERY OTHER TUES 6AM - 2:30PM.

A QC Analyst is an entry level position for individuals who use their understanding of science to perform the basic and critical experimental work of day-to-day analysis, including generation and analysis of data. Their work is “hands on” in an analytical lab and requires analytical testing, computer operating, record keeping, and report writing abilities. This position performs the quality testing needed for raw material, in-process, finished goods, stability, and cleaning validation analysis, while following all regulations and SOP’s.

Duties may include but are not limited to:

• Perform efficient/reliable/high quality analytical testing in accordance with USP/NF/EP/JP/FCC/etc. or customer supplied guidelines. Typical testing may include Dissolution, Titration, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC, etc.

• Maintain accurate written records of all analysis performed.

• Accurately interpret and effectively communicate analytical results and issues.

• Schedule daily tasks in an organized and efficient manner.

• General knowledge of the use and operation of basic laboratory equipment.

• Calibrate and maintain lab equipment and instrumentation.

• Responsible for operating in a safe manner, must be familiar with basic laboratory and chemical hygiene practices

• Become proficient in standard operating procedures and test methods.

• Ability to work in a “flow to the work” team environment.

• In combination with other lab personnel, be responsible for a clean and safe work environment.

• Perform peer review of analytical testing and write up.

• Write SOPs on an as needed basis.

• Other duties as required in support of Catalent Pharma Solutions high performance

Education or Equivalent Requirements:

Minimum education required to perform the job:

• Bachelor’s degree in a scientific field.

• Alternate degrees in a non-scientific field may be accepted with at least 2 years of relevant experience in a material testing laboratory.

Minimum skills/knowledge required to perform job:

• Ability to multi-task with high efficiency.

• Ability to work well under pressure, maintain efficiency, and meet deadlines.

• Proficient in English. Ability to communicate effectively.

• Basic knowledge of lab safety and the ability to work safely with chemicals of varying potency.

• General computer literacy including use of Microsoft Word and Excel.

• Ability to perform analytical testing while standing for long periods of time

• Accurate testing on the first attempt under pressure of production details.

• Experience in the pharmaceutical industry preferred.

Preferred Qualifications:

Desirable skills, knowledge and/or experience that enhance job performance

• Bachelor’s degree in Chemistry or Biology

• Work Experience – 2 – 5 years in Quality, Laboratory, Clinical or Chemical manufacturing role (including internships or co-op experience).

Pay Rate: $27.76/Hr

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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